Back to results

The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 3

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Aspirin

Tirofiban

Clopidogrel

Prasugrel

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All comer study where all patients undergoing coronary bypass surgery (CABG) will be randomized to one of the four treatment groups

Exclusion Criteria:

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.
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

Sites / Locations

Prince Sultan Cardiac CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Aspirin alone

Tirofoban

Clopidogrel

Prasugrel

Arm Description

Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding

Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators

Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators

Outcomes

Primary Outcome Measures

Venous graft patency

Venous graft patency as assessed by computed tomographic angiography or coronary angiography

Secondary Outcome Measures

Major cardiac events (MACE)

Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization

Full Information

NCT ID

NCT01598337

First Posted

May 9, 2012

Last Updated

May 14, 2012

Sponsor

Prince Sultan Cardiac Center, Adult Cardiology Department.

1. Study Identification

Unique Protocol Identification Number

NCT01598337

Brief Title

The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency

Official Title

The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prince Sultan Cardiac Center, Adult Cardiology Department.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aspirin alone

Arm Type

Active Comparator

Arm Title

Tirofoban

Arm Type

Experimental

Arm Description

Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding

Arm Title

Clopidogrel

Arm Type

Experimental

Arm Description

Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators

Arm Title

Prasugrel

Arm Type

Experimental

Arm Description

Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily

Intervention Type

Drug

Intervention Name(s)

Tirofiban

Intervention Description

Tirofiban infusion as specified by investigators to start after hemostasis been established

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

75 mg orally started 6-8hours before surgery

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Intervention Description

10 mg daily as per instructions of investigators

Primary Outcome Measure Information:

Title

Venous graft patency

Description

Venous graft patency as assessed by computed tomographic angiography or coronary angiography

Time Frame

At one year

Secondary Outcome Measure Information:

Title

Major cardiac events (MACE)

Description

Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization

Time Frame

At one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All comer study where all patients undergoing coronary bypass surgery (CABG) will be randomized to one of the four treatment groups Exclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hussein S Al-Amri, MD

Organizational Affiliation

Prince Sultan Cardiac Center (PSCC), Riyadh

Official's Role

Study Director

Facility Information:

Facility Name

Prince Sultan Cardiac Center

City

Riyadh

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hussein S Alamri, MD

amriheart@hotmail.com

First Name & Middle Initial & Last Name & Degree

Antonio Calafiore

First Name & Middle Initial & Last Name & Degree

Hussein S Alamri, MD

First Name & Middle Initial & Last Name & Degree

Abdulrahman M almoghairi, MD

12. IPD Sharing Statement

Learn more about this trial

The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency

We'll reach out to this number within 24 hrs