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A Study of the Antiplatelet Effects Comparing Ticagrelor (Ticag. - AZD6140) With Clopidogrel (Clop.) Responder and Non-responders

NCT ID: NCT00642811

Last Updated: 2011-10-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated the effect of Ticagrelor on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel.

Detailed Description

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Conditions

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Stable Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Aspirin + Ticagrelor

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Tablets, Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily for 2 weeks

Aspirin

Intervention Type DRUG

Tablets, Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study

2

Aspirin + Clopidogrel

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

(over encapsulated) capsule, Oral, 75 mg; 600 mg loading dose followed by 75 mg once daily for 2 weeks

Aspirin

Intervention Type DRUG

Tablets, Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study

Interventions

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Ticagrelor

Tablets, Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily for 2 weeks

Intervention Type DRUG

Clopidogrel

(over encapsulated) capsule, Oral, 75 mg; 600 mg loading dose followed by 75 mg once daily for 2 weeks

Intervention Type DRUG

Aspirin

Tablets, Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study

Intervention Type DRUG

Other Intervention Names

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Plavix

Eligibility Criteria

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Inclusion Criteria

* Patients with documented stable Coronary Artery Disease (CAD) (stable angina, previous MI history, previous history of revascularization)
* Females of child bearing potential must have a negative pregnancy test prior to receiving study drug and be willing to use a hormonal contraceptive in addition to double barrier contraception

Exclusion Criteria

* History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or coronary artery bypass graft (CABG))
* Any acute or chronic unstable condition in the past 30 days
* Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high blood pressure, low platelet count, recent major trauma
* History of intolerance or allergy to aspirin or clopidogrel
Minimum Eligible Age

18 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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Jay Horrow, MD

Role: STUDY_DIRECTOR

AstraZeneca

Paul Gurbel, md

Role: PRINCIPAL_INVESTIGATOR

Platelet & Thrombosis Research, LLC

Locations

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Research Site

Jonesboro, Arkansas, United States

Site Status

Research Site

Ormond Beach, Florida, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Research Site

Hamilton, Ontario, Canada

Site Status

Research Site

Lachine, , Canada

Site Status

Research Site

Aalborg, , Denmark

Site Status

Research Site

Aarhus, , Denmark

Site Status

Research Site

Esbjerg, , Denmark

Site Status

Research Site

Sheffield, , United Kingdom

Site Status

Countries

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United States Canada Denmark United Kingdom

References

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Jeong YH, Bliden KP, Antonino MJ, Park KS, Tantry US, Gurbel PA. Usefulness of the VerifyNow P2Y12 assay to evaluate the antiplatelet effects of ticagrelor and clopidogrel therapies. Am Heart J. 2012 Jul;164(1):35-42. doi: 10.1016/j.ahj.2012.03.022. Epub 2012 Jun 13.

Reference Type DERIVED
PMID: 22795280 (View on PubMed)

Jeong YH, Bliden KP, Tantry US, Gurbel PA. High on-treatment platelet reactivity assessed by various platelet function tests: is the consensus-defined cut-off of VASP-P platelet reactivity index too low? J Thromb Haemost. 2012 Mar;10(3):487-9. doi: 10.1111/j.1538-7836.2011.04604.x. No abstract available.

Reference Type DERIVED
PMID: 22212857 (View on PubMed)

Tantry US, Bliden KP, Wei C, Storey RF, Armstrong M, Butler K, Gurbel PA. First analysis of the relation between CYP2C19 genotype and pharmacodynamics in patients treated with ticagrelor versus clopidogrel: the ONSET/OFFSET and RESPOND genotype studies. Circ Cardiovasc Genet. 2010 Dec;3(6):556-66. doi: 10.1161/CIRCGENETICS.110.958561. Epub 2010 Nov 15.

Reference Type DERIVED
PMID: 21079055 (View on PubMed)

Gurbel PA, Bliden KP, Butler K, Antonino MJ, Wei C, Teng R, Rasmussen L, Storey RF, Nielsen T, Eikelboom JW, Sabe-Affaki G, Husted S, Kereiakes DJ, Henderson D, Patel DV, Tantry US. Response to ticagrelor in clopidogrel nonresponders and responders and effect of switching therapies: the RESPOND study. Circulation. 2010 Mar 16;121(10):1188-99. doi: 10.1161/CIRCULATIONAHA.109.919456. Epub 2010 Mar 1.

Reference Type DERIVED
PMID: 20194878 (View on PubMed)

Other Identifiers

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D5130C00030

Identifier Type: -

Identifier Source: org_study_id