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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014