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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: C. Michael Gibson, MS, MD
• Collaborator: Genentech, Inc.
• Treatments: Tenecteplase; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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