INSTANT: INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial

NCT00638976 | Completed Phase 3 DMC

• 1 other identifier: Fondazione Mediolanum 001/2007
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Disease

Keywords

Eptifibatide; IV eptifibatide; GP IIB/IIIA inhibitors; DES stent

Study Arms (2)

1.Integrilin, GSK

OTHER

Pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide (Integrilin, GSK) vs matched placebo.

Drug: eptifibatide

2

PLACEBO COMPARATOR

Pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide (Integrilin, GSK) vs matched placebo.

Drug: placebo

Interventions

eptifibatide DRUG

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

1.Integrilin, GSK

placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS: lead

Study Sites (1)

Mediolanum Cardio Research

Milan, 20144, Italy

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Eptifibatide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2008
• First Posted: March 19, 2008
• Study Start: November 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 28, 2010

Record last verified: 2010-05

Locations

IT (1)