NCT00103350

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

Enrollment Period

1.9 years

First QC Date

February 7, 2005

Last Update Submit

May 16, 2008

Conditions

Myocardial Infarction

Keywords

myocardial infarctioninfarct sizeangioplastypercutaneous coronary interventionAcute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Safety and pharmacokinetics of TG100-115

Secondary Outcomes (1)

  • Impact of TG100-115 on infarct size

Interventions

TG100-115DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Holmes, MD

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

3-(2,4-diamino-6-(3-hydroxyphenyl)pteridin-7-yl)phenol

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2005

First Posted

February 8, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

January 1, 2008

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations

US(1)