Heart Attack |
Acute Myocardial Infraction; Myocardial Infarction |
Clinical Trial: Safety of TG100-115 for Heart Attack Treated with Angioplasty
This study is currently recruiting patients.
|
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| Myocardial Infarction | Drug: TG100-115 | Phase I Phase II |
MedlinePlus related topics: Heart Attack
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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
Secondary Outcomes: Impact of TG100-115 on infarct size
Expected Total Enrollment: 100
Study start: January 2005
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
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.
Location and Contact Information
Jolene Shorr 858 964-2166 shorr@targegen.com
Minnesota
David Holmes, MD, Rochester, Minnesota, 55905, United States; Recruiting
More Information
Record last reviewed: February 2005
Last Updated: February 7, 2005
Record first received: February 7, 2005
ClinicalTrials.gov Identifier: NCT00103350
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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