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Safety of TG100-115 for Heart Attack Treated With Angioplasty

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TG100-115
Sponsored by
TargeGen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, infarct size, angioplasty, percutaneous coronary intervention, Acute Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • David Holmes, MD

Outcomes

Primary Outcome Measures

Safety and pharmacokinetics of TG100-115

Secondary Outcome Measures

Impact of TG100-115 on infarct size

Full Information

First Posted
February 7, 2005
Last Updated
May 16, 2008
Sponsor
TargeGen
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1. Study Identification

Unique Protocol Identification Number
NCT00103350
Brief Title
Safety of TG100-115 for Heart Attack Treated With Angioplasty
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 Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
TargeGen

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, infarct size, angioplasty, percutaneous coronary intervention, Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TG100-115
Primary Outcome Measure Information:
Title
Safety and pharmacokinetics of TG100-115
Secondary Outcome Measure Information:
Title
Impact of TG100-115 on infarct size

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
David Holmes, MD
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Safety of TG100-115 for Heart Attack Treated With Angioplasty

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