The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin.

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

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: Eptifibatide

Criteria

Inclusion Criteria:

• male or female able to understand and sign a witnessed informed consent,

• age ≥ 18 years

• patients with stable (Canadian Cardiovascular Society I-IV) or unstable angina pectoris (but with the most recent anginal episode occurring >48 hours before the procedure [provided that the most recent CK-MB mass levels are within the limits of normal]) or documented silent ischemia

• stable hemodynamic conditions (systolic blood pressure>100, heart rate>40 and <100)

• no clinical and ECG changes suggestive of ongoing acute or recent (<48 hours) myocardial infarction.

Exclusion Criteria:

• female sex with childbearing potential

• age <18 years

• ongoing or recent episode (<48 hours) of unstable coronary artery disease (including both ST-elevation and non-ST-elevation acute coronary syndromes) without normalization of CK-MB mass levels

• administration of any GP IIb/IIIa inhibitors during the previous 2 weeks,

• serum creatinine >2.5 mg/dl or > 350 micromols/l

• ongoing serious bleeding or bleeding diathesis

• previous stroke in the last 6 months

• major surgery within the previous 6 weeks

• platelet count <100,000 per mm3

• ejection Fraction below 30%

• known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or sensitivity to contrast which cannot be adequately pre-medicated

• hemodynamic instability (systolic blood pressure<100 mm Hg; heart rate<40 bpm or >100 bpm; complex ventricular arrhythmias; atrioventricular block) requiring balloon counterpulsation or inotropic support

• simultaneous participation in another device or drug study (patient must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study)

• positive clinical history for intracranial neoplasia, arterio-venous malformation, aneurysm

• INR ≥ 2.0 or prothrombin time 1.2 times upper limit of normality

• clinically manifested reduced liver function

• programmed surgery within one month