- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00638976
INSTANT: INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)
May 27, 2010 updated by: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Randomized, blind controlled, Multicenter, spontaneous, prospective trial, roughly 20 enrolling centers in Italy, placebo and active drug supply given by GlaxoSmithKline (GSK).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Milan, Italy, 20144
- Mediolanum Cardio Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1.Integrilin, GSK
Pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide (Integrilin, GSK) vs matched 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
|
Placebo Comparator: 2
Pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide (Integrilin, GSK) vs matched 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
March 13, 2008
First Submitted That Met QC Criteria
March 18, 2008
First Posted (Estimate)
March 19, 2008
Study Record Updates
Last Update Posted (Estimate)
May 28, 2010
Last Update Submitted That Met QC Criteria
May 27, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fondazione Mediolanum 001/2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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