Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

NCT ID: NCT01603082

Last Updated: 2015-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI

Detailed Description

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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)

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor

Ticagrelor - 180 mg loading dose

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

180 mg loading dose

Clopidogrel

Clopidogrel - 600 mg loading dose

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

600 mg loading dose

Interventions

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Ticagrelor

180 mg loading dose

Intervention Type DRUG

Clopidogrel

600 mg loading dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn F. Carlson, MD

Role: STUDY_DIRECTOR

AstraZeneca Pharmaceuticals, Wilmington, DE 19850-5437 USA

Locations

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Research Site

Birmingham, Alabama, United States

Site Status

Research Site

San Francisco, California, United States

Site Status

Research Site

Washington D.C., District of Columbia, United States

Site Status

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Jacksonville, Florida, United States

Site Status

Research Site

Ypsilanti, Michigan, United States

Site Status

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Minneapolis, Minnesota, United States

Site Status

Research Site

Tupelo, Mississippi, United States

Site Status

Research Site

North Kansas City, Missouri, United States

Site Status

Research Site

Belleville, New Jersey, United States

Site Status

Research Site

New York, New York, United States

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Research Site

The Bronx, New York, United States

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Research Site

Greensboro, North Carolina, United States

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Cincinnati, Ohio, United States

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Research Site

Oklahoma City, Oklahoma, United States

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Research Site

Tyler, Texas, United States

Site Status

Research Site

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28356282 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26868683 (View on PubMed)

Other Identifiers

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D5130L00014

Identifier Type: -

Identifier Source: org_study_id