Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078013
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2004-02-13
Brief Title:
MCC-135 as Adjunct Therapy to Primary Percutaneous Coronary Intervention in ST-Segment Elevation Acute Myocardial Infarction Patients
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Organization:
Mitsubishi Tanabe Pharma Corporation
Study Overview
Official Title:
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
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 111 ratio to 1 of 3 treatment groups A B and C Group A will receive MCC-135 45 mgkg48 hours Group B will receive MCC-135 90 mgkg48 hours and Group C will receive placebo48 hours Three hundred thirty patients with a TIMI flow grade of 01 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 ie symptoms of myocardial ischemia Examples of ischemic symptoms include chest arm andor 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
Patients will be randomized in a 111 ratio to 1 of 3 treatment groups A B and C Group A will receive MCC-135 45 mgkg48 hours Group B will receive MCC-135 90 mgkg48 hours and Group C will receive placebo48 hours Three hundred thirty patients with a TIMI flow grade of 01 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 ie symptoms of myocardial ischemia Examples of ischemic symptoms include chest arm andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None