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

April 26, 2009 updated by: Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo p.o
EXPERIMENTAL: clopidogrel by chewing
Drug: clopidogrel by chewing
600 mg clopidogrel by chewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Platelet aggregation and bleeding events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

April 26, 2009

First Submitted That Met QC Criteria

April 26, 2009

First Posted (ESTIMATE)

April 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2009

Last Update Submitted That Met QC Criteria

April 26, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-08 -5397-SM-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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