The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)

This study has been terminated.

(The study was stopped prematurely due to slow enrolment without code breaking.)

Sponsor:

Information provided by (Responsible Party):

Giuseppe Biondi Zoccai, University of Turin, Italy

ClinicalTrials.gov Identifier:

NCT01454440

First received: October 6, 2011

Last updated: October 18, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 6, 2011
Last Updated Date	October 18, 2011
Start Date ^ICMJE	October 2007
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 18, 2011)	Abnormal CK-MB level post-PCI [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] The primary end point will be the rate of elevated post-procedural peak CK-MB mass ratio values (ie above the upper limit of normal [ULN], eg 1.01*ULN, according to each participating hospital laboratory).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01454440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)
Official Title ^ICMJE	A RANDOMIZED TRIAL COMPARING EPTIFIBATIDE AND PLACEBO IN PATIENTS WITH DIFFUSE CORONARY DISEASE UNDERGOING DRUG-ELUTING STENTING
Brief Summary	Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin.
Detailed Description	BACKGROUND: Despite the availability of several potent antithrombotic agents, the optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions is still debated. Aim of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial (INSTANT) will be to assess the safety and efficacy of routine usage of the glycoprotein IIb/IIIa inhibitor eptifibatide in subjects already treated with aspirin and clopidogrel, and undergoing implantation of at least 2 drug-eluting stents in the same lesion, thus identifying a clinically stable but anatomically complex patient subset. DESIGN: This will be a single-blind, placebo-controlled multicenter randomized trial METHODS: Patients with stable coronary artery disease, undergoing percutaneous coronary intervention (PCI) by means of implantation of >33 mm of DES (eg with two 23-mm DES, or one 32-mm and one 12-mm DES), will be randomized, after administration of aspirin and clopidogrel (600 mg loading dose recommended), to eptifibatide and unfractioned heparin according to the ESPRIT protocol vs placebo and unfractioned heparin. Blood draws for CK-MB mass, total CK and cardiac troponin levels will be taken at baseline, 6 and 12 hours post-procedurally. Patients will be followed for clinical events by direct visit or phone contact up to 6 months. The primary end-point of the study will be the rate of abnormal post-PCI CK-MB mass values. Secondary end-points will be: the composite of cardiac death, non-fatal myocardial infarction (MI), urgent target vessel revascularization (TVR), and thrombotic bailout GpIIb/IIIa inhibitor therapy within 180 days, and in-hospital, 1-month and 6-month major adverse cardiovascular events (MACE), defined as the composite of cardiac death, non-fatal MI, or urgent TVR. IMPLICATIONS: The INSTANT Study will test for the first time the beneficial impact of routine GpIIb/IIIa inhibition on top of double oral antiplatelet treatment in clinically stable yet anatomically complex patients undergoing DES-implantation. Results of this single-blind randomized trial will provide important insights to improve the management strategy of patients and outcomes in the current DES era.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Coronary Artery Disease
Intervention ^ICMJE	Drug: Eptifibatide Intravenous eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure) vs placebo.
Study Arm (s)	Experimental: Eptifibatide Intravenous eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure). Intervention: Drug: Eptifibatide Placebo Comparator: Placebo Intervention: Drug: Eptifibatide
Publications *	Biondi-Zoccai G, Valgimigli M, Margheri M, Marzocchi A, Lettieri C, Stabile A, Petronio AS, Binetti G, Bolognese L, Bellone P, Sardella G, Contarini M, Sheiban I, Marra S, Piscione F, Romeo F, Colombo A, Sangiorgi G. Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: the INtegrilin plus STenting to Avoid myocardial Necrosis Trial. Am Heart J. 2012 May;163(5):835.e1-7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	91
Completion Date	October 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: male or female able to understand and sign a witnessed informed consent, age ≥ 18 years patients with stable (Canadian Cardiovascular Society I-IV) or unstable angina pectoris (but with the most recent anginal episode occurring >48 hours before the procedure [provided that the most recent CK-MB mass levels are within the limits of normal]) or documented silent ischemia stable hemodynamic conditions (systolic blood pressure>100, heart rate>40 and <100) no clinical and ECG changes suggestive of ongoing acute or recent (<48 hours) myocardial infarction. 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) without normalization of CK-MB mass levels 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% 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; atrioventricular block) requiring balloon counterpulsation or inotropic support simultaneous participation 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, arterio-venous malformation, aneurysm INR ≥ 2.0 or prothrombin time 1.2 times upper limit of normality clinically manifested reduced liver function programmed surgery within one month
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01454440
Other Study ID Numbers ^ICMJE	2007−002617−39
Has Data Monitoring Committee	Yes
Responsible Party	Giuseppe Biondi Zoccai, University of Turin, Italy
Study Sponsor ^ICMJE	University of Turin, Italy
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Turin, Italy
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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