Status:
COMPLETED
Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance
Lead Sponsor:
Università degli Studi di Ferrara
Conditions:
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneou...
Detailed Description
This study will investigate the effect of treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 300mg or 600mg clopidogrel) on the rate of periprocedural myocardial infa...
Eligibility Criteria
Inclusion
- All Patients older than 18 years scheduled for coronary angiography and/or PCI will be enrolled. \[Patients should be CK-MB negative (to avoid CK washout with revascularization) and also cTnI/T negative whereas other high-risk features will not lead to patient exclusion.
- All consecutive patients with stable or unstable troponin and CK-MB negative coronary artery disease showing aspirin and or clopidogrel resistance (ACR) will be enrolled. These include:
- Patients with clinical indication to undergo angiography for possible revascularisation.
- Patients with ACR in whom catheter-based coronary intervention is planned based on previous angiogram.
Exclusion
- Patients who can not give informed consent or have a life expectancy of \< 1 year
- Evolving or Ongoing myocardial infarction (MI) (Persistence of or developing Q wave or ST segment elevation at ECG with or without typical chest pain or typical rapid rise and fall CK-MB or new LBBB) or patients in whom the treating physician intends to use a Gp IIB/IIIa inhibitors.
- Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days
- Serum creatinine more than 2.5 mg/dl (221 micromol/L)
- Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year
- Previous stroke or TIA or any intracranial pathology in the last six months
- Major surgery or trauma within the previous six weeks
- Platelet count \< 100.000 per cubic mm or HCT ,33% or Hb \< 11 gm/dL
- Subjects who received low-molecular-weight heparin within the 24 hours prior to randomization
- Subjects with an allergy or intolerance to aspirin, heparin, clopidogrel, or tirofiban
- Patients with severe hypertension (SBP \> 180 mm Hg or DBP \> 110 mm Hg) or in cardiogenic shock (SBP 80 mm Hg or below for \> 30 minutes) or requiring IABP
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00398463
Start Date
May 1 2006
End Date
May 1 2011
Last Update
July 1 2011
Active Locations (1)
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1
Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Fe, Italy, 44100