EUCTR2006-003684-32-ITActive, not recruitingNot Applicable
Integrilin plus stenting to avoid myocardial necrosis trial. Pilot Study - ND
OSPEDALE S. RAFFAELE0 sites320 target enrollmentStarted: October 3, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 320
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •male or female able to understand and sign a witnessed informed consent; age /equal 18 years; patients with stable or unstable anginapectoris or documented silent ischemia; stable hemodynamic conditions; no clinical ECG changes suggestive of ongoing acute or recent 48 hours myocardial infarction;angiographic inclusion criteria see the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 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 The patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, rapamycin, 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; AV block requiring balloon counterpulsation or inotropic support. The patient is simultaneously participating 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, AV malformation, aneurysm. INR 8805; 2.0 or prothrombin time 1.2 times upper limit of normality Clinically manifested reduced liver function Programmed surgery within six months
Investigators
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