Safety of TG100-115 for Heart Attack Treated With Angioplasty

This study has been completed.

First Received: February 7, 2005 Last Updated: May 16, 2008 History of Changes

Sponsored by:	TargeGen
Information provided by:	TargeGen
ClinicalTrials.gov Identifier:	NCT00103350

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	Intervention	Phase
Myocardial Infarction	Drug: TG100-115	Phase I Phase II

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

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

Further study details as provided by TargeGen:

Primary Outcome Measures:

Safety and pharmacokinetics of TG100-115

Secondary Outcome Measures:

Impact of TG100-115 on infarct size

Estimated Enrollment:	100
Study Start Date:	January 2005
Study Completion Date:	January 2008
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103350

Locations

United States, Minnesota
David Holmes, MD
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

TargeGen

More Information

No publications provided

Study ID Numbers:	TG001-03
Study First Received:	February 7, 2005
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00103350 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by TargeGen:

myocardial infarction
infarct size
angioplasty
percutaneous coronary intervention
Acute Myocardial Infarction

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009