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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:
ClinicalTrials.gov Identifier:
NCT01235351
First Posted: November 5, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
Sanofi
Information provided by:
The TIMI Study Group
  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: Quadruple (Participant, Care Provider, 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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 2, 2010
First Posted: November 5, 2010
Last Update Posted: October 12, 2017
Last Verified: October 2011

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
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
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors