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

NCT01454440 | Terminated Phase 4 DMC

• 1 other identifier: 2007-002617-39
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Eptifibatide; Percutaneous coronary intervention; stable coronary artery disease; percutaneous coronary intervention (PCI); DES

Outcome Measures

Primary Outcomes (1)

• Abnormal CK-MB level post-PCI

  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).

  2 weeks

Study Arms (2)

Eptifibatide

EXPERIMENTAL

Intravenous eptifibatide (double bolus \[180 microg/kg\] followed by infusion \[2 microg/kg per minute\] for 18 to 24 hours after the procedure).

Drug: Eptifibatide

Placebo

PLACEBO COMPARATOR

Drug: Eptifibatide

Interventions

Eptifibatide DRUG

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.

Eptifibatide; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

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) 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin

Turin, TO, 10126, Italy

Location

Related Publications (1)

• 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. doi: 10.1016/j.ahj.2012.02.009.

  PMID: 22607870 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Eptifibatide

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Cardiology

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 19, 2011
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

IT (1)