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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
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Percutaneous Coronary Intervention
 Drug: Clopidogrel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by The TIMI Study Group:

Primary Outcome Measures:
  • Change in measurements of platelet inhibition [ Time Frame: Approximately every 2 weeks for 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: October 2010
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clopidogrel 75 mg daily Drug: Clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
Experimental: Clopidogrel 150 mg daily Drug: Clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
Experimental: Clopidogrel 225 mg daily Drug: Clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
Experimental: Clopidogrel 300 mg daily Drug: Clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235351

Locations
United States, Massachusetts
TIMI Study Group
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
The TIMI Study Group
Bristol-Myers Squibb
Sanofi
  More Information

No publications provided by The TIMI Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: TIMI Study Group (Jessica Mega, MD, MPH), TIMI Study Group
ClinicalTrials.gov Identifier: NCT01235351     History of Changes
Other Study ID Numbers: TIMI 56
Study First Received: November 2, 2010
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The TIMI Study Group:
Myocardial infarction
Percutaneous coronary intervention
Clopidogrel
Genetics
Platelet Function

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013