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

NCT00078013 | Completed Phase 2

• 1 other identifier: MCC-135-A02
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myocardial Infarction

Keywords

AMI; STEMI; Infarct; acute myocardial infarction with ST segment elevation

Interventions

MCC-135 DRUG

Eligibility Criteria

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

You may qualify if:

• Written informed consent must be obtained from the patient (or, in accordance with state and federal laws and IRB regulations, emergency consent procedures may be employed) before enrollment into the study.
• The patient is a male or female at least 18 years of age.
• The patient has an estimated weight between 50 kg (110 lbs) and 140 kg (308 lbs).
• The patient is suspected to have his/her first-documented ST-segment elevation AMI.
• The patient has symptoms of ischemia of at least 20 minutes continuous duration, the onset of which occurred \< 6 hours prior to study drug infusion. 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.
• The patient has
• Anterior MI: \> 2 mm ST elevation in at least two contiguous leads out of V1-V4
• Inferior MI: \> 2 mm ST elevation in at least two of II, III, and aVF, with \> 10 mm elevation summed for all leads (14, 15)
• Infero-apical MI: \> 1 mm ST elevation in at least two of II, III, and aVF, with both V5 and V6
• Infero-lateral MI: \> 1 mm ST elevation in at least two of II, III, and aVF, with both I and aVL
• Infero-posterior MI: \> 1 mm ST elevation in II, III, and aVF, with \> 1 mm ST depression in at least two leads out of V1-V3
• Women of childbearing potential must have a negative pregnancy test.

You may not qualify if:

• The patient has a past history of ST-segment elevation MI.
• The patient has a pathologic arrhythmia or is considered electrically unstable (K+, Ca2+).
• The patient has thrombolytic therapy planned.
• The patient is in cardiogenic shock unresponsive to IV fluid.
• The patient has severe bradycardia with heart rate \<45 beats/minute.
• The patient has a pre-existing diagnosis of chronic heart failure (NYHA class III-IV).
• The patient has left bundle branch block.
• The patient has any cardiomyopathy or pericarditis.
• The patient has a history of clinically significant bleeding within the last 3 months.
• The patient has had any type of major trauma, major surgery, or eye, spinal cord, or brain surgery within the last 3 months that, in the opinion of the investigator, would compromise the patient's response to the standard of care.
• The patient has a history of clinically significant hepatic disturbance.
• The patient has a history of chronic renal impairment.
• The patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 6 months.
• The patient is a woman who is pregnant or lactating.
• The patient is currently receiving therapy with catecholamines/sympathomimetics, phosphodiesterase inhibitors, or phosphodiesterase inhibitors with calcium sensitizing activity. Patients will be permitted to enter the study if these drugs were discontinued more than 5 half-lives prior to randomization.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Massachusetts General Hospital/ Harvard Medical School

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction

Interventions

MCC 135

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2004
• First Posted: February 18, 2004
• Study Start: April 1, 2003
• Study Completion: August 1, 2004
• Last Updated: June 24, 2005

Record last verified: 2005-03

Locations

US (1)