CClinicalTrials.gg
Status unknownNCT01598337Updated May 15, 2012

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

A Phase 3 interventional study of Aspirin and Tirofiban in Coronary Artery Disease, sponsored by Prince Sultan Cardiac Center, Adult Cardiology Department.. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-15.

Sponsored by Prince Sultan Cardiac Center, Adult Cardiology Department. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 200 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Prince Sultan Cardiac Center, Adult Cardiology Department. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Aspirin alone

    Drug: Aspirin · Drug: Tirofiban · Drug: Clopidogrel · Drug: Prasugrel

  • Experimental
    Tirofoban

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

    Drug: Tirofiban · Drug: Clopidogrel · Drug: Prasugrel

  • Experimental
    Clopidogrel

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

    Drug: Tirofiban · Drug: Clopidogrel · Drug: Prasugrel

  • Experimental
    Prasugrel

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

    Drug: Tirofiban · Drug: Clopidogrel · Drug: Prasugrel

Interventions

  • DrugAspirin

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

  • DrugTirofiban

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

  • DrugClopidogrel

    75 mg orally started 6-8hours before surgery

  • DrugPrasugrel

    10 mg daily as per instructions of investigators

06

What researchers measure

Primary outcomes

  1. Venous graft patency

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

    Time frame: At one year

Secondary outcomes

  1. Major cardiac events (MACE)

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

    Time frame: At one year

07

Study locations

1 of 1 sites recruiting
  • Prince Sultan Cardiac Center
    Riyadh, Saudi Arabia
    • Hussein S Alamri, MD · Contact · amriheart@hotmail.com
    • Antonio Calafiore · Principal investigator
    • Hussein S Alamri, MD · Principal investigator
    • Abdulrahman M almoghairi, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01598337
Lead sponsor
Prince Sultan Cardiac Center, Adult Cardiology Department.
Responsible party
Abdulrahman Al-Moghairi (Principal Investigator, Prince Sultan Cardiac Center, Adult Cardiology Department.) — Principal investigator
First posted
May 15, 2012
Start date
Apr 2011
Primary completion
Dec 2013 (estimated)
Last update
May 15, 2012

Study contacts

Hussein S Al-Amri, MD
study director · Prince Sultan Cardiac Center (PSCC), Riyadh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion