Status:
TERMINATED
The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)
Lead Sponsor:
University of Turin, Italy
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ES...
Detailed Description
BACKGROUND: Despite the availability of several potent antithrombotic agents, the optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions is still deba...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01454440
Start Date
October 1 2007
End Date
October 1 2009
Last Update
October 19 2011
Active Locations (1)
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1
University of Turin
Turin, TO, Italy, 10126