Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Platlet Aggregation; Major Bleeding Outcomes
Intervention: clopidogrel by chewing (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sheba Medical Center
Summary
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.
Clinical Details
Official title: Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Platelet aggregation and bleeding events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sheba_medical_center, Ramat-Gan, Israel; Not yet recruiting
Shlomo Matetzky, M.D, Phone: 972-3-5302504, Email: Shlomi.Matetzky@sheba.health.gov.il
Elad Asher, M.D, Sub-Investigator
Sheba Medical Center, Cardiac Institute, Tel Hashomer, Israel; Recruiting
Shlomi Matetzky, MD, Phone: 972-3-530-2504, Email: shlomi.matetzky@sheba.health.gov.il
Elad Asher, MD, Phone: 972-3-530-2504, Email: elad.asher@sheba.health.gov.il
Additional Information
Related publications: Gurbel PA, Bliden KP, Hiatt BL, O'Connor CM. Clopidogrel for coronary stenting: response variability, drug resistance, and the effect of pretreatment platelet reactivity. Circulation. 2003 Jun 17;107(23):2908-13. Epub 2003 Jun 9. Matetzky S, Shenkman B, Guetta V, Shechter M, Bienart R, Goldenberg I, Novikov I, Pres H, Savion N, Varon D, Hod H. Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction. Circulation. 2004 Jun 29;109(25):3171-5. Epub 2004 Jun 7.
Starting date: April 2009
Ending date: June 2011
Last updated: April 26, 2009
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