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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by The TIMI Study Group.
Recruitment status was:  Active, not recruiting
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
November 2, 2010
October 4, 2011
October 2010
October 2011   (Final data collection date for primary outcome measure)
Change in measurements of platelet inhibition [ Time Frame: Approximately every 2 weeks for 8 weeks ]
Same as current
Complete list of historical versions of study NCT01235351 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Percutaneous Coronary Intervention
Drug: Clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
275
Not Provided
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria (major):

  1. Between 18 and 75 years of age, inclusive.
  2. 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.
  3. Clinically stable and at least 4 weeks following the MI or PCI.

Exclusion Criteria (major):

  1. Conditions that alter platelet function.
  2. Conditions that increase bleeding risk.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01235351
TIMI 56
Yes
Not Provided
Not Provided
Not Provided
TIMI Study Group (Jessica Mega, MD, MPH), TIMI Study Group
The TIMI Study Group
  • Bristol-Myers Squibb
  • Sanofi
Not Provided
The TIMI Study Group
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP