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Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS (dal-GenE)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dalcetrapib
Placebo
Sponsored by
DalCor Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial.
  • AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigational testing site (ITS)
  • Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
  • Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C <100 mg/dl (<2.6 mmol/L).

Exclusion Criteria:

  • Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
  • Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one method of contraception*
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Last known hemoglobin <10 g/dL
  • Index ACS event presumed due to uncontrolled hypertension

(*) Varies by region

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dalcetrapib

Placebo

Arm Description

Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets

Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets

Outcomes

Primary Outcome Measures

Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke
All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke, as positively adjudicated by the CEC.

Secondary Outcome Measures

Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Hospitalization for ACS (With Electrocardiogram Abnormalities) or Unanticipated Coronary Revascularization
All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, hospitalization for acute coronary syndrome (with electrocardiogram abnormalities) or unanticipated coronary revascularization, as positively adjudicated by the CEC.
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure
All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The secondary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite secondary endpoint, which included death from cardiovascular causes, cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for new or worsening heart failure, as positively adjudicated by the CEC.

Full Information

First Posted
August 13, 2015
Last Updated
October 9, 2022
Sponsor
DalCor Pharmaceuticals
Collaborators
The Montreal Health Innovations Coordinating Center (MHICC), Medpace, Inc., Roche Molecular Systems, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02525939
Brief Title
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Acronym
dal-GenE
Official Title
A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
October 2021 (Actual)
Study Completion Date
October 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DalCor Pharmaceuticals
Collaborators
The Montreal Health Innovations Coordinating Center (MHICC), Medpace, Inc., Roche Molecular Systems, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.
Detailed Description
This is an event driven study to reach statistical power given all other assumptions. Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. Additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 months for the collection of study endpoints. Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype. The test is investigational and test procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dalcetrapib
Arm Type
Active Comparator
Arm Description
Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets
Intervention Type
Drug
Intervention Name(s)
dalcetrapib
Intervention Description
Cholesterol Ester Transfer Protein inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablets
Primary Outcome Measure Information:
Title
Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke
Description
All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke, as positively adjudicated by the CEC.
Time Frame
From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months)
Secondary Outcome Measure Information:
Title
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Hospitalization for ACS (With Electrocardiogram Abnormalities) or Unanticipated Coronary Revascularization
Description
All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, hospitalization for acute coronary syndrome (with electrocardiogram abnormalities) or unanticipated coronary revascularization, as positively adjudicated by the CEC.
Time Frame
From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Title
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure
Description
All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The secondary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite secondary endpoint, which included death from cardiovascular causes, cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for new or worsening heart failure, as positively adjudicated by the CEC.
Time Frame
From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial. AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigational testing site (ITS) Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C <100 mg/dl (<2.6 mmol/L). Exclusion Criteria: Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one method of contraception* New York Heart Association (NYHA) Class III or IV heart failure Last known hemoglobin <10 g/dL Index ACS event presumed due to uncontrolled hypertension (*) Varies by region
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald M Black, MD
Organizational Affiliation
DalCor Pharmaceuticals
Official's Role
Study Director
Facility Information:
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Alexander City
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Tallahassee
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Covington
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Bangor
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Biddeford
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Lewiston
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Research Site
City
Ypsilanti
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Coon Rapids
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Duluth
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Saint Cloud
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Washington
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
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City
Bridgewater
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Linden
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Somerset
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Summit
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Research Site
City
Johnson City
State/Province
New York
Country
United States
Facility Name
Research Site
City
New Windsor
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Pinehurst
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Rocky Mount
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Minot
State/Province
North Dakota
Country
United States
Facility Name
Research Site
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Zanesville
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Butler
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Chambersburg
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Langhorne
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
York
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
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City
Greeneville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Oak Ridge
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Kingwood
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Victoria
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Wichita Falls
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Layton
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Winchester
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
La Crosse
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Bahía Blanca
Country
Argentina
Facility Name
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City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Cordoba
Country
Argentina
Facility Name
Research Site
City
Coronel Suarez
Country
Argentina
Facility Name
Research Site
City
Corrientes
Country
Argentina
Facility Name
Research Site
City
Esperanza
Country
Argentina
Facility Name
Research Site
City
Junin
Country
Argentina
Facility Name
Research Site
City
La Plata
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
Country
Argentina
Facility Name
Research Site
City
Mendoza
Country
Argentina
Facility Name
Research Site
City
Moron
Country
Argentina
Facility Name
Research Site
City
Quilmes
Country
Argentina
Facility Name
Research Site
City
Rosario
Country
Argentina
Facility Name
Research Site
City
San Juan
Country
Argentina
Facility Name
Research Site
City
San Luis
Country
Argentina
Facility Name
Research Site
City
San Martin
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
Country
Argentina
Facility Name
Research Site
City
San Nicolas
Country
Argentina
Facility Name
Research Site
City
Santa Fe
Country
Argentina
Facility Name
Research Site
City
Santa Rosa
Country
Argentina
Facility Name
Research Site
City
Tucuman
Country
Argentina
Facility Name
Research Site
City
Venado Tuerto
Country
Argentina
Facility Name
Research Site
City
Vicente Lopez
Country
Argentina
Facility Name
Research Site
City
Villa Allende
Country
Argentina
Facility Name
Research Site
City
Villa Maria
Country
Argentina
Facility Name
Research Site
City
Bruce
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Gosford
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Saint Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Cairns
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Chermside
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Douglas
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Milton
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Redcliffe
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Elizabeth Vale
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Woodville South
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Research Site
City
Epping
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Joondalup
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Murdoch
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Braunau Am Inn
Country
Austria
Facility Name
Research Site
City
Feldkirch
Country
Austria
Facility Name
Research Site
City
Krems
Country
Austria
Facility Name
Research Site
City
Linz
Country
Austria
Facility Name
Research Site
City
Vienna
Country
Austria
Facility Name
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City
Wiener Neustadt
Country
Austria
Facility Name
Research Site
City
Wien
Country
Austria
Facility Name
Research Site
City
Aalst
Country
Belgium
Facility Name
Research Site
City
Bonheiden
Country
Belgium
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Genk
Country
Belgium
Facility Name
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City
Liege
Country
Belgium
Facility Name
Research Site
City
Maaseik
Country
Belgium
Facility Name
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City
Mechelen
Country
Belgium
Facility Name
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City
Ottignies
Country
Belgium
Facility Name
Research Site
City
Sint-Niklaas
Country
Belgium
Facility Name
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City
Belo Horizonte
Country
Brazil
Facility Name
Research Site
City
Blumenau
Country
Brazil
Facility Name
Research Site
City
Brasilia
Country
Brazil
Facility Name
Research Site
City
Campina Grande do Sul
Country
Brazil
Facility Name
Research Site
City
Campinas
Country
Brazil
Facility Name
Research Site
City
Campo Grande
Country
Brazil
Facility Name
Research Site
City
Curitiba
Country
Brazil
Facility Name
Research Site
City
Fortaleza
Country
Brazil
Facility Name
Research Site
City
Goiania
Country
Brazil
Facility Name
Research Site
City
Marilia
Country
Brazil
Facility Name
Research Site
City
Maringa
Country
Brazil
Facility Name
Research Site
City
Natal
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
Country
Brazil
Facility Name
Research Site
City
Recife
Country
Brazil
Facility Name
Research Site
City
Ribeirao Preto
Country
Brazil
Facility Name
Research Site
City
Salvador
Country
Brazil
Facility Name
Research Site
City
Santo André
Country
Brazil
Facility Name
Research Site
City
Sao Jose do Rio Preto
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
Country
Brazil
Facility Name
Research Site
City
Uberlandia
Country
Brazil
Facility Name
Research Site
City
Vitoria
Country
Brazil
Facility Name
Research Site
City
Blagoevgrad
Country
Bulgaria
Facility Name
Research Site
City
Dimitrovgrad
Country
Bulgaria
Facility Name
Research Site
City
Haskovo
Country
Bulgaria
Facility Name
Research Site
City
Pazardzhik
Country
Bulgaria
Facility Name
Research Site
City
Pernik
Country
Bulgaria
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sandanski
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Research Site
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Bridgewater
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Peterborough
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Granby
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Levis
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Longueuil
State/Province
Quebec
Country
Canada
Facility Name
Institut de Cardiologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
St-Charles-Borromee
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
St-Jean-sur-Richelieu
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
St-Jerome
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
St. George
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Terrebonne
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Thetford Mines
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Trois-Rivieres
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Québec
Country
Canada
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Temuco
Country
Chile
Facility Name
Research Site
City
Vina del Mar
Country
Chile
Facility Name
Research Site
City
Bilina
Country
Czechia
Facility Name
Research Site
City
Brno
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
Country
Czechia
Facility Name
Research Site
City
Jihlava
Country
Czechia
Facility Name
Research Site
City
Kladno
Country
Czechia
Facility Name
Research Site
City
Kromeriz
Country
Czechia
Facility Name
Research Site
City
Liberec
Country
Czechia
Facility Name
Research Site
City
Nachod
Country
Czechia
Facility Name
Research Site
City
Pisek
Country
Czechia
Facility Name
Research Site
City
Plzen
Country
Czechia
Facility Name
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City
Prague 2
Country
Czechia
Facility Name
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City
Prague 5
Country
Czechia
Facility Name
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City
Prague 6
Country
Czechia
Facility Name
Research Site
City
Prague
Country
Czechia
Facility Name
Research Site
City
Slany
Country
Czechia
Facility Name
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City
Trutnov
Country
Czechia
Facility Name
Research Site
City
Zlin
Country
Czechia
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
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City
Frederiksberg
Country
Denmark
Facility Name
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City
Glostrup
Country
Denmark
Facility Name
Research Site
City
Hellerup
Country
Denmark
Facility Name
Research Site
City
Herning
Country
Denmark
Facility Name
Research Site
City
Hillerod
Country
Denmark
Facility Name
Research Site
City
Kobenhavn
Country
Denmark
Facility Name
Research Site
City
Naestved
Country
Denmark
Facility Name
Research Site
City
Silkeborg
Country
Denmark
Facility Name
Research Site
City
Jyvaskyla
Country
Finland
Facility Name
Research Site
City
Oulu
Country
Finland
Facility Name
Research Site
City
Pori
Country
Finland
Facility Name
Research Site
City
Turku
Country
Finland
Facility Name
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City
Besancon
Country
France
Facility Name
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City
Bron
Country
France
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City
Clermont-Ferrand
Country
France
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City
Corbeil-Essonnes
Country
France
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City
Dijon
Country
France
Facility Name
Research Site
City
Limoges
Country
France
Facility Name
Research Site
City
Lyon
Country
France
Facility Name
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City
Montpellier
Country
France
Facility Name
Research Site
City
Paris
Country
France
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Research Site
City
Pessac
Country
France
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City
Poitiers
Country
France
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City
Toulouse
Country
France
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City
Tourcoing
Country
France
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City
Valenciennes
Country
France
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City
Aachen
Country
Germany
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City
Berlin
Country
Germany
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City
Bochum
Country
Germany
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City
Bremen
Country
Germany
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City
Chemnitz
Country
Germany
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City
Coburg
Country
Germany
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City
Dresden
Country
Germany
Facility Name
Research Site
City
Erfurt
Country
Germany
Facility Name
Research Site
City
Fuerth
Country
Germany
Facility Name
Research Site
City
Heidelberg
Country
Germany
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Research Site
City
Leipzig
Country
Germany
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Research Site
City
Mainz
Country
Germany
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City
Monchengladbach
Country
Germany
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City
Munich
Country
Germany
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City
Baja
Country
Hungary
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City
Balatonfured
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
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Research Site
City
Eger
Country
Hungary
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Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Hatvan
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
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Research Site
City
Pecs
Country
Hungary
Facility Name
Research Site
City
Szekesfehervar
Country
Hungary
Facility Name
Research Site
City
Szombathely
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
Country
Hungary
Facility Name
Research Site
City
Afula
Country
Israel
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Beer Sheva
Country
Israel
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City
Bnei Brak
Country
Israel
Facility Name
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City
Haifa
Country
Israel
Facility Name
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City
Holon
Country
Israel
Facility Name
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City
Jerusalem
Country
Israel
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City
Kfar Saba
Country
Israel
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City
Nahariya
Country
Israel
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City
Nazareth
Country
Israel
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City
Petach-Tikva
Country
Israel
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City
Poriyya 'Illit
Country
Israel
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City
Rehovot
Country
Israel
Facility Name
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City
Safed
Country
Israel
Facility Name
Research Site
City
Tel Aviv
Country
Israel
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City
Tel Hashomer
Country
Israel
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Research Site
City
Zerifin
Country
Israel
Facility Name
Research Site
City
Ancona
Country
Italy
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City
Ascoli Piceno
Country
Italy
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City
Cagliari
Country
Italy
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City
Casarano
Country
Italy
Facility Name
Research Site
City
Cortona
Country
Italy
Facility Name
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City
Empoli
Country
Italy
Facility Name
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City
Firenze
Country
Italy
Facility Name
Research Site
City
Foggia
Country
Italy
Facility Name
Research Site
City
Giugliano in Campania
Country
Italy
Facility Name
Research Site
City
Gubbio
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Novara
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
Facility Name
Research Site
City
Sanremo
Country
Italy
Facility Name
Research Site
City
Saronno
Country
Italy
Facility Name
Research Site
City
Scorrano
Country
Italy
Facility Name
Research Site
City
Seriate
Country
Italy
Facility Name
Research Site
City
Torino
Country
Italy
Facility Name
Research Site
City
Treviglio
Country
Italy
Facility Name
Research Site
City
's-Hertogenbosch
Country
Netherlands
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Arnhem
Country
Netherlands
Facility Name
Research Site
City
Capelle Aan Den IJssel
Country
Netherlands
Facility Name
Research Site
City
Den Haag
Country
Netherlands
Facility Name
Research Site
City
Deventer
Country
Netherlands
Facility Name
Research Site
City
Doetinchem
Country
Netherlands
Facility Name
Research Site
City
Ede
Country
Netherlands
Facility Name
Research Site
City
Goes
Country
Netherlands
Facility Name
Research Site
City
Gouda
Country
Netherlands
Facility Name
Research Site
City
Hoogeveen
Country
Netherlands
Facility Name
Research Site
City
Hoorn
Country
Netherlands
Facility Name
Research Site
City
Leeuwarden
Country
Netherlands
Facility Name
Research Site
City
Leiden
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Schiedam
Country
Netherlands
Facility Name
Research Site
City
Sneek
Country
Netherlands
Facility Name
Research Site
City
Tiel
Country
Netherlands
Facility Name
Research Site
City
Tilburg
Country
Netherlands
Facility Name
Research Site
City
Uden
Country
Netherlands
Facility Name
Research Site
City
Veldhoven
Country
Netherlands
Facility Name
Research Site
City
Venlo
Country
Netherlands
Facility Name
Research Site
City
Zaandam
Country
Netherlands
Facility Name
Research Site
City
Zutphen
Country
Netherlands
Facility Name
Research Site
City
Christchurch
Country
New Zealand
Facility Name
Research Site
City
Dunedin
Country
New Zealand
Facility Name
Research Site
City
Grafton
Country
New Zealand
Facility Name
Research Site
City
Hamilton
Country
New Zealand
Facility Name
Research Site
City
Hastings
Country
New Zealand
Facility Name
Research Site
City
Lower Hutt
Country
New Zealand
Facility Name
Research Site
City
Nelson
Country
New Zealand
Facility Name
Research Site
City
New Plymouth
Country
New Zealand
Facility Name
Research Site
City
Rotorua
Country
New Zealand
Facility Name
Research Site
City
Takapuna
Country
New Zealand
Facility Name
Research Site
City
Wellington
Country
New Zealand
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Elblag
Country
Poland
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Kielce
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Mragowo
Country
Poland
Facility Name
Research Site
City
Olawa
Country
Poland
Facility Name
Research Site
City
Oswiecim
Country
Poland
Facility Name
Research Site
City
Plock
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Ruda Slaska
Country
Poland
Facility Name
Research Site
City
Rzeszow
Country
Poland
Facility Name
Research Site
City
Sopot
Country
Poland
Facility Name
Research Site
City
Sroda Wielkopolska
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Zamosc
Country
Poland
Facility Name
Research Site
City
Almada
Country
Portugal
Facility Name
Research Site
City
Braga
Country
Portugal
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Faro
Country
Portugal
Facility Name
Research Site
City
Leiria
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Senhora da Hora
Country
Portugal
Facility Name
Research Site
City
Setubal
Country
Portugal
Facility Name
Research Site
City
Bayamon
Country
Puerto Rico
Facility Name
Research Site
City
Caguas
Country
Puerto Rico
Facility Name
Research Site
City
Ponce
Country
Puerto Rico
Facility Name
Research Site
City
Arad
Country
Romania
Facility Name
Research Site
City
Baia Mare
Country
Romania
Facility Name
Research Site
City
Braila
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Buzau
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
Country
Romania
Facility Name
Research Site
City
Craiova
Country
Romania
Facility Name
Research Site
City
Oradea
Country
Romania
Facility Name
Research Site
City
Pitesti
Country
Romania
Facility Name
Research Site
City
Timisoara
Country
Romania
Facility Name
Research Site
City
Arkhangelsk
Country
Russian Federation
Facility Name
Research Site
City
Barnaul
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Research Site
City
Irkutsk
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
Country
Russian Federation
Facility Name
Research Site
City
Kirovsk
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Omsk
Country
Russian Federation
Facility Name
Research Site
City
Orenburg
Country
Russian Federation
Facility Name
Research Site
City
Penza
Country
Russian Federation
Facility Name
Research Site
City
Petrozavodsk
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saratov
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
Country
Russian Federation
Facility Name
Research Site
City
Tula
Country
Russian Federation
Facility Name
Research Site
City
Tyumen
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Bardejov
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Lucenec
Country
Slovakia
Facility Name
Research Site
City
Namestovo
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Bloemfontein
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Gatong
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Kuils River
Country
South Africa
Facility Name
Research Site
City
Paarl
Country
South Africa
Facility Name
Research Site
City
Parow
Country
South Africa
Facility Name
Research Site
City
Somerset West
Country
South Africa
Facility Name
Research Site
City
Worcester
Country
South Africa
Facility Name
Research Site
City
A Coruna
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Hospitalet del Llobregat
Country
Spain
Facility Name
Research Site
City
Lleida
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Malaga
Country
Spain
Facility Name
Research Site
City
Sabadell
Country
Spain
Facility Name
Research Site
City
Salamanca
Country
Spain
Facility Name
Research Site
City
Sant Joan
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
Country
Spain
Facility Name
Research Site
City
Seville
Country
Spain
Facility Name
Research Site
City
Tarragona
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Vigo
Country
Spain
Facility Name
Research Site
City
Falun
Country
Sweden
Facility Name
Research Site
City
Karlshamn
Country
Sweden
Facility Name
Research Site
City
Koping
Country
Sweden
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Orebro
Country
Sweden
Facility Name
Research Site
City
Umea
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
Facility Name
Research Site
City
Vasteras
Country
Sweden
Facility Name
Research Site
City
Geneva
Country
Switzerland
Facility Name
Research Site
City
Lugano
Country
Switzerland
Facility Name
Research Site
City
Afyonkarahisar
Country
Turkey
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Kadikoy
Country
Turkey
Facility Name
Research Site
City
Kayseri
Country
Turkey
Facility Name
Research Site
City
Mersin
Country
Turkey
Facility Name
Research Site
City
Samsun
Country
Turkey
Facility Name
Research Site
City
Sivas
Country
Turkey
Facility Name
Research Site
City
Dubai
Country
United Arab Emirates
Facility Name
Research Site
City
Sharjah
Country
United Arab Emirates
Facility Name
Research Site
City
Ayr
Country
United Kingdom
Facility Name
Research Site
City
Barnet
Country
United Kingdom
Facility Name
Research Site
City
Basildon
Country
United Kingdom
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
Country
United Kingdom
Facility Name
Research Site
City
Bradford
Country
United Kingdom
Facility Name
Research Site
City
Bristol
Country
United Kingdom
Facility Name
Research Site
City
Burton Upon Trent
Country
United Kingdom
Facility Name
Research Site
City
Chelmsford
Country
United Kingdom
Facility Name
Research Site
City
Chertsey
Country
United Kingdom
Facility Name
Research Site
City
Clydebank
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Craigavon
Country
United Kingdom
Facility Name
Research Site
City
Dartford
Country
United Kingdom
Facility Name
Research Site
City
Dudley
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Harrow
Country
United Kingdom
Facility Name
Research Site
City
High Wycombe
Country
United Kingdom
Facility Name
Research Site
City
Hull
Country
United Kingdom
Facility Name
Research Site
City
Inverness
Country
United Kingdom
Facility Name
Research Site
City
Kirkcaldy
Country
United Kingdom
Facility Name
Research Site
City
Lanark
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Lincoln
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
Country
United Kingdom
Facility Name
Research Site
City
Londonderry
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Luton
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Newcastle
Country
United Kingdom
Facility Name
Research Site
City
Newport
Country
United Kingdom
Facility Name
Research Site
City
Northampton
Country
United Kingdom
Facility Name
Research Site
City
Nuneaton
Country
United Kingdom
Facility Name
Research Site
City
Paisley
Country
United Kingdom
Facility Name
Research Site
City
Redhill
Country
United Kingdom
Facility Name
Research Site
City
Romford
Country
United Kingdom
Facility Name
Research Site
City
Rotherham
Country
United Kingdom
Facility Name
Research Site
City
Salford
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
Country
United Kingdom
Facility Name
Research Site
City
Stevenage
Country
United Kingdom
Facility Name
Research Site
City
Stockport
Country
United Kingdom
Facility Name
Research Site
City
Stockton on Tees
Country
United Kingdom
Facility Name
Research Site
City
Swindon
Country
United Kingdom
Facility Name
Research Site
City
Taunton
Country
United Kingdom
Facility Name
Research Site
City
Telford
Country
United Kingdom
Facility Name
Research Site
City
Truro
Country
United Kingdom
Facility Name
Research Site
City
West Bromwich
Country
United Kingdom
Facility Name
Research Site
City
Westcliff on Sea
Country
United Kingdom
Facility Name
Research Site
City
Wigan
Country
United Kingdom
Facility Name
Research Site
City
Worcester
Country
United Kingdom
Facility Name
Research Site
City
Worthing
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35856777
Citation
Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Gregoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dube MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374. Erratum In: Eur Heart J. 2022 Sep 20;:
Results Reference
derived
PubMed Identifier
34173811
Citation
Black DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093.
Results Reference
derived
PubMed Identifier
32087417
Citation
Tardif JC, Dube MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.
Results Reference
derived

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Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS

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