NCT01598337

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2.7 years

First QC Date

May 9, 2012

Last Update Submit

May 14, 2012

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Venous graft patency

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

    At one year

Secondary Outcomes (1)

  • Major cardiac events (MACE)

    At one year

Study Arms (4)

Aspirin alone

ACTIVE COMPARATOR
Drug: AspirinDrug: TirofibanDrug: ClopidogrelDrug: 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

Drug: TirofibanDrug: ClopidogrelDrug: 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

Drug: TirofibanDrug: ClopidogrelDrug: Prasugrel

Prasugrel

EXPERIMENTAL

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

Drug: TirofibanDrug: ClopidogrelDrug: Prasugrel

Interventions

AspirinDRUG

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

Aspirin alone
TirofibanDRUG

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

Aspirin aloneClopidogrelPrasugrelTirofoban
ClopidogrelDRUG

75 mg orally started 6-8hours before surgery

Aspirin aloneClopidogrelPrasugrelTirofoban
PrasugrelDRUG

10 mg daily as per instructions of investigators

Aspirin aloneClopidogrelPrasugrelTirofoban

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

AspirinTirofibanClopidogrelPrasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperazines

Study Officials

  • Hussein S Al-Amri, MD

    Prince Sultan Cardiac Center (PSCC), Riyadh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 15, 2012

Study Start

April 1, 2011

Primary Completion

December 1, 2013

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

SA(1)