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

NCT ID: NCT00889044

Last Updated: 2009-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Platlet Aggregation Major Bleeding Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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clopidogrel by chewing

Group Type EXPERIMENTAL

clopidogrel by chewing

Intervention Type DRUG

600 mg clopidogrel by chewing

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo p.o

Interventions

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clopidogrel by chewing

600 mg clopidogrel by chewing

Intervention Type DRUG

Placebo

Placebo p.o

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Locations

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Sheba Medical Center, Cardiac Institute

Tel Litwinsky, Tel Hashomer, Israel

Site Status RECRUITING

Sheba_medical_center

Ramat Gan, , Israel

Site Status NOT_YET_RECRUITING

Countries

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Israel

Facility Contacts

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Shlomi Matetzky, MD

Role: primary

972-3-530-2504

Elad Asher, MD

Role: backup

972-3-530-2504

Shlomo Matetzky, M.D

Role: primary

972-3-5302504

References

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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. doi: 10.1161/01.CIR.0000072771.11429.83. Epub 2003 Jun 9.

Reference Type BACKGROUND
PMID: 12796140 (View on PubMed)

Matetzky S, Shenkman B, Guetta V, Shechter M, Beinart 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. doi: 10.1161/01.CIR.0000130846.46168.03. Epub 2004 Jun 7.

Reference Type BACKGROUND
PMID: 15184279 (View on PubMed)

Other Identifiers

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SHEBA-08 -5397-SM-CTIL

Identifier Type: -

Identifier Source: org_study_id

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