Safety of TG100-115 for Heart Attack Treated With Angioplasty

Sponsor

TargeGen (Industry)

Overall Status

Completed

CT.gov ID

NCT00103350

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis of this study is that TG100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces heart muscle damage.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: TG100-115	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective Study to Evaluate the Safety and Potential Efficacy of Single, Increasing Doses of TG100-115 in Subjects Undergoing Percutaneous Coronary Intervention for Acute Anterior ST Elevation Myocardial Infarction

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Jan 1, 2008

Outcome Measures

Primary Outcome Measures

Safety and pharmacokinetics of TG100-115 []

Secondary Outcome Measures

Impact of TG100-115 on infarct size []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-80 yrs
ECG patterns consistent with an acute anterior myocardial infarction with ST segment elevation of 2mm in two contiguous ECG leads among leads V1-V4.
Have prolonged, continuous (lasting at least 20 mins) signs and symptoms of myocardial ischemia not eliminated with nitrates.
Intent to proceed to primary PCI within 6 hours of chest pain onset
Sign an informed consent form and be willing to attend follow-up visits for safety and other study assessments.

Exclusion Criteria:

Female of childbearing potential.
History of previous myocardial infarction.
History of congestive heart failure.
Requirement for a cardiac pacemaker or defibrillator.
Cardiogenic shock.
Patients previously treated with thrombolytic therapy.
Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease.