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

Sponsor:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00889044

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
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:

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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
clopidogrel by chewing: Experimental	Drug: clopidogrel by chewing 600 mg clopidogrel by chewing
Placebo: Placebo Comparator	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

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:

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.

Responsible Party:	Sheba Medical Center ( Dr. Shlomi Matetzky )
Study ID Numbers:	SHEBA-08 -5397-SM-CTIL
Study First Received:	April 26, 2009
Last Updated:	April 26, 2009
ClinicalTrials.gov Identifier:	NCT00889044 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Therapeutic Uses
Clopidogrel
Hematologic Agents
Platelet Aggregation Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010