INSTANT: INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial

Cardiovascular Disease Clinical Trial

— INSTANT  

Official title:

INSTANT: INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638976
• Other study ID #: Fondazione Mediolanum 001/2007
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2008
• Last updated: May 27, 2010
• Start date: November 2007
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Randomized, blind controlled, Multicenter, spontaneous, prospective trial, roughly 20 enrolling centers in Italy, placebo and active drug supply given by GlaxoSmithKline (GSK).

Description:

The Objective of the trial is 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Candidates for this study must meet all of the following criteria:

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

• Age = 18 yo

• Patients with stable (CCS 1-4) or unstable angina pectoris (but with the most recent anginal episode occurring >48 hours before the procedure) or documented silent ischemia

• Stable Hemodynamic conditions (systolic BP > 100 HR > 40 < 100).

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

• Angiographic evidence of a de novo lesion > 50% requiring implantation of two DES in overlapping with a total stent length > 33 mm and reference vessel diameter between 2.5 and 4.0 mm (by visual estimation) in one coronary vessel. Multiple lesions in the same vessels can be included but at least one lesion should require implantation of two DES in overlapping with a total stent length > 33 mm. The definition of multivessel disease requires an intention to treat at least two lesions (with a least one with the characteristics reported above) in two different major epicardial segments. For example, the presence of a lesion in the left anterior descending artery and in the obtuse marginal or the presence of a lesions in the right postero-lateral branch and in a diagonal branch will qualify as multivessel. The presence of lesions in the left anterior descending artery and in the diagonal branch will not qualify as multivessel. Bifurcation lesions and ostial lesions can be included, but only if at least two DES in overlapping with a total stent length > 33 mm are implanted in the same branch. When treating diffuse lesion in the same vessel, overlapping stenting is recommended with high pressure (>14 atm post-dilation) of the overlap zone. There is no maximum stent length to treat one coronary vessel.

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 with a creatinine clearance <40mL/min

• 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, 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 enrolment in this study.

• Positive clinical history for intracranial neoplasia, AV malformation, aneurysm.

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

• Clinically manifested reduced liver function

• Programmed surgery within six months

Angiographic Exclusion Criteria:

• DES implantation in a chronic total occlusion or for the treatment of in-stent restenosis.

• Treatment of lesions where the operator feels necessary the usage of rotactional atherectomy

• Vessel size < 2.25 mm or > 5 mm (by visual estimation).

• Previous implantation of a bare/DES in the target lesion

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Myocardial Infarction

Intervention

Drug:
• eptifibatide
Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure
• placebo
Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure

Locations

Country	Name	City	State
Italy	Mediolanum Cardio Research	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus

Country where clinical trial is conducted

Italy,