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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Eptifibatide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A RANDOMIZED TRIAL COMPARING EPTIFIBATIDE AND PLACEBO IN PATIENTS WITH DIFFUSE CORONARY DISEASE UNDERGOING DRUG-ELUTING STENTING

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • 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).


Enrollment: 91
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
Placebo Comparator: Placebo 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454440

Locations
Italy
University of Turin
Turin, TO, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
  More Information

No publications provided by University of Turin, Italy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giuseppe Biondi Zoccai, Assistant Professor in Cardiology, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01454440     History of Changes
Other Study ID Numbers: 2007−002617−39
Study First Received: October 6, 2011
Last Updated: October 18, 2011
Health Authority: Italy: Agenzia Italiana del Farmaco

Keywords provided by University of Turin, Italy:
Coronary artery disease
Eptifibatide
Percutaneous coronary intervention
stable coronary artery disease
percutaneous coronary intervention (PCI)
DES

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Eptifibatide
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014