Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56 (ELEVATE-TIMI56)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Bristol-Myers Squibb

Sanofi

Information provided by:

The TIMI Study Group

ClinicalTrials.gov Identifier:

NCT01235351

First received: November 2, 2010

Last updated: October 4, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 2010
Last Updated Date	October 4, 2011
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 3, 2010)	Change in measurements of platelet inhibition [ Time Frame: Approximately every 2 weeks for 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01235351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Official Title ^ICMJE	Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Brief Summary	To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Myocardial Infarction Percutaneous Coronary Intervention
Intervention ^ICMJE	Drug: Clopidogrel Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
Study Arm (s)	Active Comparator: Clopidogrel 75 mg daily Intervention: Drug: Clopidogrel Experimental: Clopidogrel 150 mg daily Intervention: Drug: Clopidogrel Experimental: Clopidogrel 225 mg daily Intervention: Drug: Clopidogrel Experimental: Clopidogrel 300 mg daily Intervention: Drug: Clopidogrel
Publications *	Mega JL, Hochholzer W, Frelinger AL 3rd, Kluk MJ, Angiolillo DJ, Kereiakes DJ, Isserman S, Rogers WJ, Ruff CT, Contant C, Pencina MJ, Scirica BM, Longtine JA, Michelson AD, Sabatine MS. Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiovascular disease. JAMA. 2011 Nov 23;306(20):2221-8. Epub 2011 Nov 16.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	275
Completion Date	Not Provided
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria (major): Between 18 and 75 years of age, inclusive. Have an indication for the use of clopidogrel defined as either spontaneous MI [hospitalized with final diagnosis of MI, excluding periprocedural or definite secondary MI (e.g., due to anemia or hypertensive emergency)] or PCI within the past 6 months. Clinically stable and at least 4 weeks following the MI or PCI. Exclusion Criteria (major): Conditions that alter platelet function. Conditions that increase bleeding risk.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01235351
Other Study ID Numbers ^ICMJE	TIMI 56
Has Data Monitoring Committee	Yes
Responsible Party	TIMI Study Group (Jessica Mega, MD, MPH), TIMI Study Group
Study Sponsor ^ICMJE	The TIMI Study Group
Collaborators ^ICMJE	Bristol-Myers Squibb Sanofi
Investigators ^ICMJE	Not Provided
Information Provided By	The TIMI Study Group
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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