Overview

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