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Safety of TG100-115 for Heart Attack Treated With Angioplasty

This study has been completed.
Sponsor:
Information provided by:
TargeGen
ClinicalTrials.gov Identifier:
NCT00103350
First received: February 7, 2005
Last updated: May 16, 2008
Last verified: May 2008
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

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

ClinicalTrials.gov Identifier: NCT00103350     History of Changes
Obsolete Identifiers: NCT00104208
Other Study ID Numbers: TG001-03
Study First Received: February 7, 2005
Last Updated: May 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by TargeGen:
myocardial infarction
infarct size
angioplasty
percutaneous coronary intervention
Acute Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013