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Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI

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 April 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889044
First Posted: April 28, 2009
Last Update Posted: April 28, 2009
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.
Information provided by:
Sheba Medical Center
  Purpose
Since the absorption of clopidogrel through the gastrointestinal tract is limited, we want to examine whether adding clopidogrel by chewing will overcome the limited gastrointestinal absorption, and hence will improve the prevention of platelet aggregation.

Condition Intervention Phase
Platlet Aggregation Major Bleeding Outcomes Drug: clopidogrel by chewing Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Platelet aggregation and bleeding events [ Time Frame: 6 months ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clopidogrel by chewing Drug: clopidogrel by chewing
600 mg clopidogrel by chewing
Placebo Comparator: Placebo Drug: Placebo
Placebo p.o

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female older than 18 years old with non-ST myocardial infarction

Exclusion Criteria:

  • Current treatment with anticoagulation medication, any type of cerebro vascular event in the past, active bleeding, active peptic ulcer disease, pregnant women, any inability to sign an informed consent of participate in the study
  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): NCT00889044


Locations
Israel
Sheba_medical_center Not yet recruiting
Ramat-Gan, Israel
Contact: Shlomo Matetzky, M.D    972-3-5302504    Shlomi.Matetzky@sheba.health.gov.il   
Sub-Investigator: Elad Asher, M.D         
Sheba Medical Center, Cardiac Institute Recruiting
Tel Hashomer, Israel
Contact: Shlomi Matetzky, MD    972-3-530-2504    shlomi.matetzky@sheba.health.gov.il   
Contact: Elad Asher, MD    972-3-530-2504    elad.asher@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
  More Information

Publications:
Responsible Party: Dr. Shlomi Matetzky, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00889044     History of Changes
Other Study ID Numbers: SHEBA-08 -5397-SM-CTIL
First Submitted: April 26, 2009
First Posted: April 28, 2009
Last Update Posted: April 28, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
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