patients with diffuse CAD undergoing percutaneous treatment on a native coronary vassel with planned implantation of 33 mm of DES with reference vessel diameter 2.25-4.0 mm. MedDRA version: 6.1 Level: PT Classification code 10011076
Conditions
Interventions
Trade Name: INTEGRILIN*IV 100ML 0,75MG/ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Eptifibatide
CAS Number: 148031-34-9
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: compare the efficacy and, secondarily, the safety and effectiveness of pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide in comparison to placebo in patients with diffuse CAD undergoing multiple DES implantation.;Secondary Objective: to compare the safety and effectiveness of pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide in comparison to placebo in patients with diffuse CAD undergoing multiple DES implantation.;Primary end point(s): rate of post procedural peak CK-MB ratio values above the upper limit of normal. | — |
Countries
Italy
Outcome results
None listed