Coronary Artery DiseasePhase 3NCT01598337
The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency
A Phase 3 study testing Aspirin, Tirofiban and Clopidogrel in people with Coronary Artery Disease, run by Prince Sultan Cardiac Center, Adult Cardiology Department. at 1 site in Saudi Arabia.
Trial summary
This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aspirin, Tirofiban and Clopidogrel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2011to Dec 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All comer study where all patients undergoing coronary bypass surgery (CABG) will be randomized to one of the four treatment groups
Who cannot join
- Acute myocardial infarction (AMI) or cardiogenic shock
- Aortic dissection
- Mechanical valves.
- Contraindication to antiplatelets or aggrastat.
- Active bleeding or high risk of bleeding.
- History of hemorrhagic stroke any time.
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- Recent history of embolic stroke or transient ischemic attack (TIA) less than 3 months.
- Active peptic ulcer disease (PUD).
- Liver derangement.
- Warfarin use.
- Heparin-induced thrombocytopenia (HIT) syndrome.
- Thrombocytopenia (platelet count <100,000/mm3), disorders of platelet function
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Prince Sultan Cardiac Center
Riyadh
Hussein S Alamri, MD, amriheart@hotmail.com
Antonio Calafiore
About this study
Official title: The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency
This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG.
Read the detailed description
Coronary artery bypass graft (CABG) surgery is a commonly used revascularization strategy in patients with severe coronary artery disease. Saphenous vein grafts (SVGs) are the most frequently used conduits for this procedure. Unlike arterial grafts, SVGs are particularly susceptible to occlusive thrombosis during the first post-operative year, which exposes patients to increased risks of death, myocardial infarction, and repeat revascularization.
This study is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG. Patients will undergo planned cardiac Computed tomographic angiography (CTA) predischarge (at 1 week) and CTA/coronary angiography (CAG) at 6 months to 1 year follow-up. CTA at baseline (predischarge) and follow-up CTA/CAG at 6-12 months after CABG will be used to evaluate graft patency.
- Conditions
- Coronary Artery Disease
- Being tested
- Aspirin, Tirofiban, Clopidogrel, Prasugrel
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily
TirofibanDrug
Tirofiban infusion as specified by investigators to start after hemostasis been established
ClopidogrelDrug
75 mg orally started 6-8hours before surgery
PrasugrelDrug
10 mg daily as per instructions of investigators
| Study group | Role | What they receive |
|---|---|---|
| Aspirin alone | Active comparator | Not described Receives: Drug: Aspirin; Drug: Tirofiban; Drug: Clopidogrel; Drug: Prasugrel |
| Tirofoban | Experimental | Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding Receives: Drug: Tirofiban; Drug: Clopidogrel; Drug: Prasugrel |
| Clopidogrel | Experimental | Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators Receives: Drug: Tirofiban; Drug: Clopidogrel; Drug: Prasugrel |
| Prasugrel | Experimental | Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators Receives: Drug: Tirofiban; Drug: Clopidogrel; Drug: Prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous graft patency
Venous graft patency as assessed by computed tomographic angiography or coronary angiography
Measured: At one year
Secondary outcomes (1)
Major cardiac events (MACE)
Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization
Measured: At one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince Sultan Cardiac Center, Adult Cardiology Department.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Al-Moghairi, Prince Sultan Cardiac Center, Adult Cardiology Department.
- Investigators
- Hussein S Al-Amri, MD, Study director, Prince Sultan Cardiac Center (PSCC), Riyadh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598337
- Sponsor's protocol ID
- PSCC002CT
- Status last verified
- May 2012
- First submitted
- 9 May 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency
- ClinicalTrials.gov ID
- NCT01598337
- Acronym / sponsor ID
- PSCC002CT
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Prince Sultan Cardiac Center, Adult Cardiology Department.University, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (estimated)
- First posted
- 15 May 2012 (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.
This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG.
Detailed description
Coronary artery bypass graft (CABG) surgery is a commonly used revascularization strategy in patients with severe coronary artery disease. Saphenous vein grafts (SVGs) are the most frequently used conduits for this procedure. Unlike arterial grafts, SVGs are particularly susceptible to occlusive thrombosis during the first post-operative year, which exposes patients to increased risks of death, myocardial infarction, and repeat revascularization.
This study is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG. Patients will undergo planned cardiac Computed tomographic angiography (CTA) predischarge (at 1 week) and CTA/coronary angiography (CAG) at 6 months to 1 year follow-up. CTA at baseline (predischarge) and follow-up CTA/CAG at 6-12 months after CABG will be used to evaluate graft patency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aspirin alone | Active comparator | Drug: Aspirin, Drug: Tirofiban, Drug: Clopidogrel, Drug: Prasugrel |
| Tirofoban | Experimental | Drug: Tirofiban, Drug: Clopidogrel, Drug: PrasugrelPatient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding |
| Clopidogrel | Experimental | Drug: Tirofiban, Drug: Clopidogrel, Drug: PrasugrelPatients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators |
| Prasugrel | Experimental | Drug: Tirofiban, Drug: Clopidogrel, Drug: PrasugrelPatients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All comer study where all patients undergoing coronary bypass surgery (CABG) will be randomized to one of the four treatment groups
Key exclusion criteria (12 listed)
- Acute myocardial infarction (AMI) or cardiogenic shock
- Aortic dissection
- Mechanical valves.
- Contraindication to antiplatelets or aggrastat.
- Active bleeding or high risk of bleeding.
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 |
|---|---|---|
| AspirinPatients continue their maintenance dose not inturrupted by surgery , 81 mg daily | Drug | Aspirin alone |
| TirofibanTirofiban infusion as specified by investigators to start after hemostasis been established | Drug | Aspirin alone, Clopidogrel, Prasugrel, Tirofoban |
| Clopidogrel75 mg orally started 6-8hours before surgery | Drug | Aspirin alone, Clopidogrel, Prasugrel, Tirofoban |
| Prasugrel10 mg daily as per instructions of investigators | Drug | Aspirin alone, Clopidogrel, Prasugrel, Tirofoban |
Primary outcome
Venous graft patency
Time frame: At one year
Venous graft patency as assessed by computed tomographic angiography or coronary angiography
1 secondary outcome
Major cardiac events (MACE)
Time frame: At one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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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.
Hussein S Al-Amri, MD study director
Prince Sultan Cardiac Center (PSCC), Riyadh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin, Tirofiban and Clopidogrel in people with Coronary Artery Disease, run by Prince Sultan Cardiac Center, Adult Cardiology Department. at 1 site in Saudi Arabia.
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 12 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 15 May 2012. 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 Saudi Arabia. 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. 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?
Venous graft patency (time frame: At one year). 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 15 May 2012.