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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 because the information has not been verified recently.
Verified April 2009 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00889044
First received: April 26, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 26, 2009
Last Updated: April 26, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014