Coronary Graft PatencyPhase 4ASAP-CABGNCT01158703
Aspirin and Plavix Following Coronary Artery Bypass Grafting
A Phase 4 study testing clopidogrel, sugar pill and Aspirin in people with Coronary Graft Patency, run by Ahmad Slim at 1 site in United States.
Trial summary
The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering the incidence of graft stenosis after coronary artery bypass grafting compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Graft Patency
- What is being tested?
- clopidogrel, sugar pill and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary artery bypass grafting, with or without cardiopulmonary bypass
- Age ≥ 18
Who cannot join
- Left ventricle ejection fraction <30%
- Emergency surgery
- Valve surgery
- Redo CABG
- Postoperative cardiogenic shock for more than 48 hours
- Postoperative bleeding or cardiac tamponade
Show all 13Show fewer
- More than 24 hours postoperative intubation course
- Requirement of postoperative anticoagulation
- Serum creatinine >1.4
- Contraindication to use of postoperative coronary CT scan
- Allergy or contraindication to aspirin or clopidogrel
- Inability to provide informed consent
- Pregnant or breast feeding females
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78234
About this study
Official title: Aspirin and Plavix Following Coronary Artery Bypass Grafting (ASAP-CABG)
The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering the incidence of graft stenosis after coronary artery bypass grafting compared to placebo.
Read the detailed description
The purpose of this study is to evaluate how well the combination of clopidogrel and aspirin lower the risk of clot forming in the bypass graft after open heart surgery. This combination has not yet been approved by the Food \& Drug Administration (FDA) for treating clots in the bypass graft. However, the FDA has not objected to its use to study its safety and effectiveness. This study will enroll approximately 150 total subjects all of which will be at Brooke Army Medical Center/Wilford Hall Medical Center. The study will be for 52 weeks from the day of surgery.
After bypass surgery and inclusion criteria is met, subjects will be placed on aspirin 81 mg once daily and placebo once daily or aspirin 81 mg once daily and clopidogrel 75mg once daily to keep the bypass grafts open after surgery. There are no studies to date comparing the two study groups A CT scan of the heart will be done 2 weeks after surgery to see if the grafts are still open. At the end of the study, at 52-weeks mark, the subjects will undergo another heart scan to evaluate the bypass grafts and see if they are still open.
Subjects will be seen on a 3 months basis until the end of the study, unless deemed necessary to return earlier for follow up. Subjects will undergo blood draw for complete blood count as part of the follow up visits to assess for safety while on the current study drug.
- Conditions
- Coronary Graft Patency
- Being tested
- clopidogrel, sugar pill, Aspirin
- Keywords
- aspirin, clopidogrel, coronary artery bypass graft, Plavix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called Plavix
clopidogrel 75mg daily by mouth daily for 12 months
sugar pillDrug
Also called placebo
sugar pill by mouth daily for 12 months
AspirinDrug
Also called ASA, acetylsalicylic acid, Ecotrin, Fasprin
aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel | Active comparator | aspirin and clopidogrel Receives: Drug: clopidogrel; Drug: Aspirin |
| sugar pill | Placebo comparator | aspirin and placebo Receives: Drug: sugar pill; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone
Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo
Measured: 52 weeks
Secondary outcomes (5)
Incidence of Bleeding Between the Two Treatment Arms
Measured: 52 weeks
Number of Major Adverse Cardiovascular Events With Combination Therapy
Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone
Measured: 52 weeks
Number of Angina Events
Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone
Measured: 52 weeks
Number of Myocardial Infarction Events
Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone
Measured: 52 weeks
Number of Thrombotic Events
Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: poor recruitment and reduction in CT surgery support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Graft PatencyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Slim
- Sponsor type
- US federal agency
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Ahmad Slim, Brooke Army Medical Center
- Investigators
- Ahmad M Slim, MD, Principal investigator, Brooke Army Medical CenterRachel Beck, MD, Study chair, Brooke Army Medical CenterWilliam Conner, MD, Study chair, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158703
- Sponsor's protocol ID
- C.2009.120
- Acronym
- ASAP-CABG
- Status last verified
- May 2015
- First submitted
- 7 Jul 2010
- Last updated
- 19 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin and Plavix Following Coronary Artery Bypass Grafting (ASAP-CABG)
- ClinicalTrials.gov ID
- NCT01158703
- Acronym / sponsor ID
- ASAP-CABG / C.2009.120
- Conditions
- Coronary Graft Patency
- Keywords
- aspirin, clopidogrel, coronary artery bypass graft, Plavix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment and reduction in CT surgery support
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ahmad SlimUS federal agency
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Posted 19 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering the incidence of graft stenosis after coronary artery bypass grafting compared to placebo.
Detailed description
The purpose of this study is to evaluate how well the combination of clopidogrel and aspirin lower the risk of clot forming in the bypass graft after open heart surgery. This combination has not yet been approved by the Food \& Drug Administration (FDA) for treating clots in the bypass graft. However, the FDA has not objected to its use to study its safety and effectiveness. This study will enroll approximately 150 total subjects all of which will be at Brooke Army Medical Center/Wilford Hall Medical Center. The study will be for 52 weeks from the day of surgery.
After bypass surgery and inclusion criteria is met, subjects will be placed on aspirin 81 mg once daily and placebo once daily or aspirin 81 mg once daily and clopidogrel 75mg once daily to keep the bypass grafts open after surgery. There are no studies to date comparing the two study groups A CT scan of the heart will be done 2 weeks after surgery to see if the grafts are still open. At the end of the study, at 52-weeks mark, the subjects will undergo another heart scan to evaluate the bypass grafts and see if they are still open.
Subjects will be seen on a 3 months basis until the end of the study, unless deemed necessary to return earlier for follow up. Subjects will undergo blood draw for complete blood count as part of the follow up visits to assess for safety while on the current study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clopidogrel | Active comparator | Drug: clopidogrel, Drug: Aspirinaspirin and clopidogrel |
| sugar pill | Placebo comparator | Drug: sugar pill, Drug: Aspirinaspirin and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing coronary artery bypass grafting, with or without cardiopulmonary bypass
- Age ≥ 18
Key exclusion criteria (13 listed)
- Left ventricle ejection fraction <30%
- Emergency surgery
- Valve surgery
- Redo CABG
- Postoperative cardiogenic shock for more than 48 hours
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 |
|---|---|---|
| clopidogrelAlso: Plavixclopidogrel 75mg daily by mouth daily for 12 months | Drug | clopidogrel |
| sugar pillAlso: placebosugar pill by mouth daily for 12 months | Drug | sugar pill |
| AspirinAlso: ASA, acetylsalicylic acid, Ecotrin, Fasprinaspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms) | Drug | clopidogrel, sugar pill |
Primary outcome
Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone
Time frame: 52 weeks
Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo
5 secondary outcomes
Incidence of Bleeding Between the Two Treatment Arms
Time frame: 52 weeks
Number of Major Adverse Cardiovascular Events With Combination Therapy
Time frame: 52 weeks
Number of Angina Events
Time frame: 52 weeks
Number of Myocardial Infarction Events
Time frame: 52 weeks
Number of Thrombotic Events
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ahmad M Slim, MD principal investigator
Brooke Army Medical Center
Rachel Beck, MD study chair
Brooke Army Medical Center
William Conner, MD study chair
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel, sugar pill and Aspirin in people with Coronary Graft Patency, run by Ahmad Slim at 1 site in United States.
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 2 inclusion and 13 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: stopped early, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2015.