Platlet AggregationPhase 3NCT00889044
Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI
A Phase 3 study testing clopidogrel by chewing in people with Platlet Aggregation and Major Bleeding Outcomes, run by Sheba Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platlet Aggregation, Major Bleeding Outcomes
- What is being tested?
- clopidogrel by chewing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2009to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female older than 18 years old with non-ST myocardial infarction
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Sheba_medical_center
Ramat Gan
Shlomo Matetzky, M.D, 972-3-5302504, Shlomi.Matetzky@sheba.health.gov.il
Elad Asher, M.D
- Recruiting
Sheba Medical Center, Cardiac Institute
Tel HaShomer, Tel Hashomer
Shlomi Matetzky, MD, 972-3-530-2504, shlomi.matetzky@sheba.health.gov.il
Elad Asher, MD, 972-3-530-2504, elad.asher@sheba.health.gov.il
About this study
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.
- Conditions
- Platlet Aggregation, Major Bleeding Outcomes
- Being tested
- clopidogrel by chewing, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel by chewingDrug
600 mg clopidogrel by chewing
PlaceboDrug
Placebo p.o
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel by chewing | Experimental | Not described Receives: Drug: clopidogrel by chewing |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation and bleeding events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Platlet AggregationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889044
- Sponsor's protocol ID
- SHEBA-08 -5397-SM-CTIL
- Status last verified
- Apr 2009
- First submitted
- 26 Apr 2009
- Last updated
- 28 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1161/01.CIR.0000072771.11429.83. Epub 2003 Jun 9.
PubMed 12796140Matetzky 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.
PubMed 15184279
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI
- ClinicalTrials.gov ID
- NCT00889044
- Acronym / sponsor ID
- SHEBA-08 -5397-SM-CTIL
- Conditions
- Platlet Aggregation, Major Bleeding Outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clopidogrel by chewing | Experimental | Drug: clopidogrel by chewing |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and Female older than 18 years old with non-ST myocardial infarction
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrel by chewing600 mg clopidogrel by chewing | Drug | clopidogrel by chewing |
| PlaceboPlacebo p.o | Drug | Placebo |
Primary outcome
Platelet aggregation and bleeding events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2009.
- Background: PubMed 12796140Gurbel 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.
- Background: PubMed 15184279Matetzky 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheba Medical Center, Cardiac Institute
Tel HaShomer, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clopidogrel by chewing in people with Platlet Aggregation and Major Bleeding Outcomes, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregation and bleeding events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889044, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2009.