NCT00078013

MCC-135 as Adjunct Therapy to Primary Percutaneous Coronary Intervention in ST-Segment Elevation Acute Myocardial Infarction Patients

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Examine the Safety and Efficacy of Intravenous MCC-135 as an Adjunct to Standard Therapy With Primary PCI in Patients Diagnosed as Having an ST Elevation Acute Myocardial Infarction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 414 (planned)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary objectives of this study are to examine the safety, tolerability, and efficacy of intravenous MCC-135 in limiting final infarct size, as measured by single photon emission computed tomography (SPECT), in patients who require percutaneous coronary intervention (PCI) for a first-documented ST-segment elevation acute myocardial infarction (AMI).

Detailed description

Patients will be male or female aged 18 years and older who present to the emergency room (ER) \< 6 hours from onset of AMI symptoms. The AMI must be confirmed by a 12-lead electrocardiogram (ECG) and documented in at least 2 leads. Each potential patient must be a candidate for primary PCI and not have thrombolytic therapy planned. To be eligible, patients must not have a prior history of ST-segment elevation MI. Patients will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups: A, B, and C. Group A will receive MCC-135 4.5 mg/kg/48 hours; Group B will receive MCC-135 9.0 mg/kg/48 hours; and Group C will receive placebo/48 hours. Three hundred thirty patients with a TIMI flow grade of 0/1 are required to complete the study. Because patients will be enrolled and will receive study medication prior to assessment of TIMI flow, it is expected that at least 414 patients may need to be randomized in order to obtain the required 330 qualified patients. All randomized patients will receive 48 hours of study medication, with ongoing assessments during this period, and will have follow-up assessments on Days 3, 4, 5, 30, and 180 as described below, regardless of preoperative TIMI flow grade. Following initial physical examination, vital signs, establishment of a separate and dedicated IV access, baseline blood sampling, and confirmation of all study eligibility requirements, patients will be randomized and begin receiving study drug as an adjunct to standard therapy. Patients will begin study drug infusion as soon as possible, but \< 6 hours following onset of AMI symptoms (i.e., symptoms of myocardial ischemia). Examples of ischemic symptoms include chest, arm, and/or jaw pain, shortness of breath, nausea, diaphoresis, or other symptoms that the investigator considers to be of ischemic origin. A negative result from a urine pregnancy test must be obtained for females of childbearing potential prior to the start of study drug infusion.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	MCC-135

Timeline

• Start date: 2003-04-01
• Completion: 2004-08-01
• First posted: 2004-02-18
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States