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Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of signed and dated informed consent before initiation of any study-related procedures
  • Male or female patients aged 18 years or older
  • Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc percutaneous coronary intervention (PCI)
  • Females must be post menopausal or surgically sterile
  • Taking aspirin as an anti-platelet medication

Exclusion Criteria:

  • Use of any thienopyridine or ticagrelor within 7 days prior to randomization
  • Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve)
  • Contraindication that ticagrelor or clopidogrel should not be administered Patient requires dialysis
  • History of intolerance or allergy to aspirin

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Ticagrelor - 180 mg loading dose

Clopidogrel - 600 mg loading dose

Outcomes

Primary Outcome Measures

Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™
Participants with low (<150) baseline PRU values were excluded.

Secondary Outcome Measures

Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™
Participants with low (<150) baseline PRU values were excluded.

Full Information

First Posted
May 18, 2012
Last Updated
November 9, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01603082
Brief Title
Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients
Official Title
A Randomized, Open-label Study to Compare the Platelet Inhibition With VerifyNow Assay of Ticagrelor Versus Clopidogrel in Troponin Negative Acute Coronary Syndrome Subjects Undergoing Ad Hoc Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI
Detailed Description
A randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)

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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor - 180 mg loading dose
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel - 600 mg loading dose
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
180 mg loading dose
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
600 mg loading dose
Primary Outcome Measure Information:
Title
Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™
Description
Participants with low (<150) baseline PRU values were excluded.
Time Frame
2 hours after the loading dose
Secondary Outcome Measure Information:
Title
Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™
Description
Participants with low (<150) baseline PRU values were excluded.
Time Frame
0.5 hours, end of PCI, and 8 hours after the loading dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent before initiation of any study-related procedures Male or female patients aged 18 years or older Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc percutaneous coronary intervention (PCI) Females must be post menopausal or surgically sterile Taking aspirin as an anti-platelet medication Exclusion Criteria: Use of any thienopyridine or ticagrelor within 7 days prior to randomization Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) Contraindication that ticagrelor or clopidogrel should not be administered Patient requires dialysis History of intolerance or allergy to aspirin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn F. Carlson, MD
Organizational Affiliation
AstraZeneca Pharmaceuticals, Wilmington, DE 19850-5437 USA
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Ypsilanti
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
North Kansas
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Belleville
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Bronx
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
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Tyler
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28356282
Citation
Sweeny JM, Angiolillo DJ, Franchi F, Rollini F, Waksman R, Raveendran G, Dangas G, Khan ND, Carlson GF, Zhao Y, Teng R, Mehran R. Impact of Diabetes Mellitus on the Pharmacodynamic Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Ad Hoc Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Mar 29;6(4):e005650. doi: 10.1161/JAHA.117.005650.
Results Reference
derived
PubMed Identifier
26868683
Citation
Angiolillo DJ, Franchi F, Waksman R, Sweeny JM, Raveendran G, Teng R, Zhao Y, Carlson G, Khan N, Mehran R. Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Patients With Low-Risk ACS Undergoing Ad Hoc PCI. J Am Coll Cardiol. 2016 Feb 16;67(6):603-613. doi: 10.1016/j.jacc.2015.11.044.
Results Reference
derived

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Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

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