Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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 percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università degli Studi di Ferrara
• Treatments: Aspirin; Clopidogrel; Krestin; polysaccharide-K; Ticlopidine; Tirofiban

Criteria

Inclusion Criteria:

1. 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.

2. 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 Criteria:

1. Patients who can not give informed consent or have a life expectancy of < 1 year

2. 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.

3. Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days

4. Serum creatinine more than 2.5 mg/dl (221 micromol/L)

5. Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year

6. Previous stroke or TIA or any intracranial pathology in the last six months

7. Major surgery or trauma within the previous six weeks

8. Platelet count < 100.000 per cubic mm or HCT ,33% or Hb < 11 gm/dL

9. Subjects who received low-molecular-weight heparin within the 24 hours prior to randomization

10. Subjects with an allergy or intolerance to aspirin, heparin, clopidogrel, or tirofiban

11. 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