Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients
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
1 other identifier
interventional
343
1 country
16
Brief Summary
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2012
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2012
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
December 11, 2015
CompletedDecember 11, 2015
November 1, 2015
1.9 years
May 18, 2012
June 1, 2015
November 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 hours after the loading dose
Secondary Outcomes (1)
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™
0.5 hours, end of PCI, and 8 hours after the loading dose
Study Arms (2)
Ticagrelor
EXPERIMENTALTicagrelor - 180 mg loading dose
Clopidogrel
ACTIVE COMPARATORClopidogrel - 600 mg loading dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Research Site
Birmingham, Alabama, United States
Research Site
San Francisco, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Ypsilanti, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Tupelo, Mississippi, United States
Research Site
North Kansas City, Missouri, United States
Research Site
Belleville, New Jersey, United States
Research Site
New York, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Tyler, Texas, United States
Research Site
Richmond, Virginia, United States
Related Publications (2)
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.
PMID: 28356282DERIVEDAngiolillo 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.
PMID: 26868683DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tomas LG Andersson, MD, PhD
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Glenn F. Carlson, MD
AstraZeneca Pharmaceuticals, Wilmington, DE 19850-5437 USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2012
First Posted
May 22, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 11, 2015
Results First Posted
December 11, 2015
Record last verified: 2015-11