A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks

Completed · Phase 2

Conditions studied: Acute Myocardial Infarction

In brief

The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during balloon angioplasty for heart attacks. We hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the site of the culprit lesion leading to reduced damage to the heart muscle.

Key facts

Study ID

NCT00604695

Run by

C. Michael Gibson, MS, MD

People needed

40

Starts

2008-07-01

Expected to finish

2011-11-01

Last updated by the study team

2012-09-07

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects (men or women) at least 18 years and less than 75 years of age and
• Ischemic discomfort ≥20 minutes and ≤6 hours of duration and
• ST elevation ≥1mm (≥0.1mV) in two contiguous limb leads OR ≥2mm (≥0.2mV) in two contiguous precordial leads and
• Occluded infarct-related artery (TIMI Flow Grade 0 or 1) at the time of coronary angiography and
• Planned primary PCI within 2 hours of hospital presentation and
• Planned or concomitant use of aspirin, clopidogrel, unfractionated heparin, and Glycoprotein IIb/IIIa inhibition with intent to stent the infarct-related artery and
• Informed consent able to be obtained

You may not qualify if…

• CLINICAL
• Age ≥75 years
• Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation.
• Uncontrolled hypertension (SBP >180 OR DBP >110) at time of enrollment.
• Cardiac arrest or arrhythmia requiring chest compressions or cardiopulmonary resuscitation.
• Known pregnancy.
• BIOCHEMICAL
• Known thrombocytopenia (platelet count <100,000)
• Known severe renal insufficiency (creatinine >4.0 mg/dL).
• INCREASED BLEEDING RISK
• Active internal bleeding
• Recent (<3 months) gastrointestinal hemorrhage
• Recent intracranial or intraspinal surgery, trauma, major surgery, or biopsy of a parenchymal organ (< 1 month)
• Known coagulopathy, platelet disorder, or history of thrombocytopenia
• Current warfarin therapy
• Known neoplasm
• Any known history of transient ischemic attack, cerebrovascular accident, or active intracranial pathology including arteriovenous malformation or aneurysm
• MEDICATIONS
• Administration of a fibrinolytic agent within 72 hours
• Known allergy or contraindication to fibrinolytics OR aspirin OR heparin OR clopidogrel
• ANGIOGRAPHIC
• Left Main Coronary artery culprit lesion
• Ostial culprit lesion (ostium of LAD, LCX, or RCA).
• Lesion in non-native coronary artery (e.g. saphenous vein graft, arterial conduit graft)
• Subjects requiring urgent coronary artery bypass grafting

Where it is running

• Northeast Georgia Heart Center, PC — Gainesville, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Emory University — Decatur, Georgia, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Crittenton Hospital Medical Center — Rochester, Michigan, United States
• Heart Consultants, PC — Freemont, Nebraska, United States
• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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