NCT00889044

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

1.7 years

First QC Date

April 26, 2009

Last Update Submit

April 26, 2009

Conditions

Platlet AggregationMajor Bleeding Outcomes

Outcome Measures

Primary Outcomes (1)

  • Platelet aggregation and bleeding events

    6 months

Study Arms (2)

clopidogrel by chewing

EXPERIMENTAL
Drug: clopidogrel by chewing

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

clopidogrel by chewingDRUG

600 mg clopidogrel by chewing

clopidogrel by chewing
PlaceboDRUG

Placebo p.o

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female older than 18 years old with non-ST myocardial infarction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheba Medical Center, Cardiac Institute

Tel Litwinsky, Tel Hashomer, Israel

RECRUITING

Sheba_medical_center

Ramat Gan, Israel

NOT YET RECRUITING

Related Publications (2)

  • 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.

    PMID: 12796140BACKGROUND

  • 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.

    PMID: 15184279BACKGROUND

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 26, 2009

First Posted

April 28, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

IL(2)