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Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS (dal-GenE-2)

Primary Purpose

Acute Coronary Syndrome

Status
Recruiting
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 (up to 3 months following the index event), will be enrolled in this trial. Both male and female subjects age 45 years and over at screening visit (V1) AA genotype at variant gene as determined by Genotype Assay Test, 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, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment. Randomization within 3 months of the index ACS event Exclusion Criteria: Females who are pregnant (negative urine 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 highly effective method of contraception. New York Heart Association (NYHA) Class III or IV heart failure Index ACS event presumed due to uncontrolled hypertension Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg at the time of randomization despite anti-hypertensive therapy Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level >3 x ULN within 6 months prior to randomization (excluding index event) History of persistent and unexplained creatine phosphokinase (CPK) levels > 5 times the ULN as assessed within 6 months prior to randomization (excluding index event) Last known eGFR < 30 mL/min/1.73m2 as assessed within 6 months prior to randomization History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years. Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dalcetrapib

Placebo

Arm Description

Dalcetrapib 600 mg (two 300 mg tablets) orally once daily

Matching dalcetrapib placebo tablets (2 tablets) orally once per day

Outcomes

Primary Outcome Measures

Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)
Time to patients experiencing major cardiovascular events

Secondary Outcome Measures

The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Time to patients experiencing major cardiovascular events
Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Time to patients experiencing first and recurrent occurrences
Fatal and non-fatal MI
Time to patients experiencing first and recurrent occurrences

Full Information

First Posted
June 15, 2023
Last Updated
October 9, 2023
Sponsor
DalCor Pharmaceuticals
Collaborators
The Montreal Health Innovations Coordinating Center (MHICC)
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1. Study Identification

Unique Protocol Identification Number
NCT05918861
Brief Title
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
Acronym
dal-GenE-2
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DalCor Pharmaceuticals
Collaborators
The Montreal Health Innovations Coordinating Center (MHICC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 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. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from 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 (up to12 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 and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 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 at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.

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
Model Description
Placebo-controlled, randomized, double-blind, parallel group, multi-center
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
With the exception of the statistician to the DSMB and the DSMB all other individuals will remain blinded until the final analysis of the primary study parameter.
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dalcetrapib
Arm Type
Experimental
Arm Description
Dalcetrapib 600 mg (two 300 mg tablets) orally once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching dalcetrapib placebo tablets (2 tablets) orally once per day
Intervention Type
Drug
Intervention Name(s)
Dalcetrapib
Other Intervention Name(s)
Cholesterol Ester Transfer Protein Inhibitor
Intervention Description
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dalcetrapib matching placebo tablets
Intervention Description
matching placebo tablets
Primary Outcome Measure Information:
Title
Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)
Description
Time to patients experiencing major cardiovascular events
Time Frame
Average of 30 months from randomization
Secondary Outcome Measure Information:
Title
The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Description
Time to patients experiencing major cardiovascular events
Time Frame
Average of 30 months from randomization
Title
Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Description
Time to patients experiencing first and recurrent occurrences
Time Frame
Average of 30 months from randomization
Title
Fatal and non-fatal MI
Description
Time to patients experiencing first and recurrent occurrences
Time Frame
Average of 30 months from randomization

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 (up to 3 months following the index event), will be enrolled in this trial. Both male and female subjects age 45 years and over at screening visit (V1) AA genotype at variant gene as determined by Genotype Assay Test, 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, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment. Randomization within 3 months of the index ACS event Exclusion Criteria: Females who are pregnant (negative urine 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 highly effective method of contraception. New York Heart Association (NYHA) Class III or IV heart failure Index ACS event presumed due to uncontrolled hypertension Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg at the time of randomization despite anti-hypertensive therapy Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level >3 x ULN within 6 months prior to randomization (excluding index event) History of persistent and unexplained creatine phosphokinase (CPK) levels > 5 times the ULN as assessed within 6 months prior to randomization (excluding index event) Last known eGFR < 30 mL/min/1.73m2 as assessed within 6 months prior to randomization History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years. Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Kallend, MBBS
Phone
+41 79 174 1830
Email
dkallend@dalcorpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Therese Heinonen, DVM
Email
theinonen@dalcorpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kallend, MBBS
Organizational Affiliation
DalCor
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Individual Site Status
Not yet recruiting
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Research Site
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Individual Site Status
Not yet recruiting
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Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
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United States
Individual Site Status
Not yet recruiting
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City
Mobile
State/Province
Alabama
ZIP/Postal Code
36602
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United States
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Not yet recruiting
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North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
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United States
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Not yet recruiting
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Torrance
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California
ZIP/Postal Code
90502
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United States
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West Hills
State/Province
California
ZIP/Postal Code
91307
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United States
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Golden
State/Province
Colorado
ZIP/Postal Code
80401
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United States
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Clearwater
State/Province
Florida
ZIP/Postal Code
33755
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United States
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Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
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United States
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Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33302
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United States
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Homestead
State/Province
Florida
ZIP/Postal Code
33030
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United States
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
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United States
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Kissimmee
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Florida
ZIP/Postal Code
32836
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United States
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Largo
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Florida
ZIP/Postal Code
33770
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United States
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Miami Lakes
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Florida
ZIP/Postal Code
33014
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United States
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Miami
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Florida
ZIP/Postal Code
33136
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United States
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Ocala
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Florida
ZIP/Postal Code
34471
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United States
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Not yet recruiting
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Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33023
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United States
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Not yet recruiting
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Pensacola
State/Province
Florida
ZIP/Postal Code
32502
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United States
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Not yet recruiting
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Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
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United States
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Not yet recruiting
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Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
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United States
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Not yet recruiting
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Tallahassee
State/Province
Florida
ZIP/Postal Code
32301
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United States
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Not yet recruiting
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Winter Haven
State/Province
Florida
ZIP/Postal Code
33881
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United States
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Acworth
State/Province
Georgia
ZIP/Postal Code
33626
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United States
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Eatonton
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Georgia
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30101
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United States
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Hazel Crest
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Illinois
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60429
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United States
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Fort Wayne
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Indiana
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46845
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United States
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Newburgh
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Indiana
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47629
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United States
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West Des Moines
State/Province
Iowa
ZIP/Postal Code
50263
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United States
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Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
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United States
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Not yet recruiting
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Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
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United States
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Not yet recruiting
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Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
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United States
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Mandeville
State/Province
Louisiana
ZIP/Postal Code
70448
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United States
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Not yet recruiting
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Bangor
State/Province
Maine
ZIP/Postal Code
04401
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United States
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Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
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United States
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Midland
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Michigan
ZIP/Postal Code
48640
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United States
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Ypsilanti
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Michigan
ZIP/Postal Code
48197
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United States
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Coon Rapids
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Minnesota
ZIP/Postal Code
55433
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United States
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Duluth
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Minnesota
ZIP/Postal Code
55802
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United States
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Saint Cloud
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Minnesota
ZIP/Postal Code
56303
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United States
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Lincoln
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Nebraska
ZIP/Postal Code
68506
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United States
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Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
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United States
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Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
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United States
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Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
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United States
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Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27006
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United States
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Not yet recruiting
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Canton
State/Province
Ohio
ZIP/Postal Code
44702
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United States
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Not yet recruiting
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45201
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United States
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Not yet recruiting
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Springfield
State/Province
Ohio
ZIP/Postal Code
45502
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United States
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Not yet recruiting
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Zanesville
State/Province
Ohio
ZIP/Postal Code
43702
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United States
Individual Site Status
Not yet recruiting
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City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
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United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
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United States
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Not yet recruiting
Facility Name
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Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
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United States
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Not yet recruiting
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Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
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United States
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Not yet recruiting
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Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
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United States
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Not yet recruiting
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Research Site
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Greeneville
State/Province
Tennessee
ZIP/Postal Code
37743
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United States
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Not yet recruiting
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Research Site
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Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
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United States
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Not yet recruiting
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Houston
State/Province
Texas
ZIP/Postal Code
77003
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United States
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Not yet recruiting
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Kingwood
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Texas
ZIP/Postal Code
77339
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United States
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Not yet recruiting
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McKinney
State/Province
Texas
ZIP/Postal Code
75071
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United States
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Not yet recruiting
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City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
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United States
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Not yet recruiting
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City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
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United States
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Not yet recruiting
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Research Site
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
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United States
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Not yet recruiting
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City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y0B3
Country
Canada
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Not yet recruiting
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City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C2T1
Country
Canada
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Not yet recruiting
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Research Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V0C6
Country
Canada
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Not yet recruiting
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Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
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Not yet recruiting
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City
Victoria
State/Province
British Columbia
Country
Canada
Individual Site Status
Not yet recruiting
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Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Not yet recruiting
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Moncton
State/Province
New Brunswick
Country
Canada
Individual Site Status
Not yet recruiting
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Research Site
City
Saint John's
State/Province
New Foundland
ZIP/Postal Code
Newfoundland
Country
Canada
Individual Site Status
Not yet recruiting
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Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
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Not yet recruiting
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Research Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R3J7
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Canada
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Not yet recruiting
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Research Site
City
Cambridge
State/Province
Ontario
Country
Canada
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Not yet recruiting
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Research Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada
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Not yet recruiting
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Research Site
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec City
ZIP/Postal Code
J4V 1L3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Longueuil
State/Province
Quebec City
ZIP/Postal Code
J4M2A5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec CIty
ZIP/Postal Code
J1H5H3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Valleyfield
State/Province
Quebec City
ZIP/Postal Code
J6T6C1
Country
Canada
Individual Site Status
Not yet recruiting
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Research Site
City
Chicoutimi
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
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City
Laval
State/Province
Quebec
Country
Canada
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Not yet recruiting
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Lévis
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T1C8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T1P7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Québec City
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L5T1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Saint Charles Borromee
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Saint-Jérôme
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Terrebonne
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Trois-Rivières
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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