Safety of TG100-115 for Heart Attack Treated With Angioplasty

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103350
• Other study ID #: TG001-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 7, 2005
• Last updated: May 16, 2008
• Start date: January 2005
• Est. completion date: January 2008

Study information

• Verified date: May 2008
• Source: TargeGen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00104208

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• TG100-115

Locations

Country	Name	City	State
United States	David Holmes, MD	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
TargeGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and pharmacokinetics of TG100-115
Secondary	Impact of TG100-115 on infarct size