Abstract | BACKGROUND: METHODS AND RESULTS: TIMI 7 was a randomized, double-blind study of Hirulog, given with 325 mg/d aspirin to 410 patients with unstable angina. Patients received a constant infusion of Hirulog for 72 hours at one of four doses: 0.02 (n = 160), 0.25 (n = 81), 0.5 (n = 88), and 1.0 (n = 81) mg.kg-1.h-1. The primary efficacy end point was "unsatisfactory outcome," defined as death, nonfatal myocardial infarction (MI), rapid clinical deterioration, or recurrent ischemic pain at rest with ECG changes by 72 hours. Unsatisfactory outcome was not different among the four dose groups: 8.1%, 6.2%, 11.4%, and 6.2% (P = NS). However, the secondary end point of death or nonfatal MI through hospital discharge occurred in 10.0% of patients treated with 0.02 mg.kg-1.h-1 compared with 3.2% of patients treated with the three higher doses of Hirulog (0.25, 0.5, and 1.0 mg.kg-1.h-1, P = .008). Only 2 of 410 patients (0.5%) experienced a major hemorrhage attributed to Hirulog. CONCLUSIONS:
|
Authors | J Fuchs, C P Cannon |
Journal | Circulation
(Circulation)
Vol. 92
Issue 4
Pg. 727-33
(Aug 15 1995)
ISSN: 0009-7322 [Print] United States |
PMID | 7641350
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Hirudins
- Peptide Fragments
- Recombinant Proteins
- Thrombin
- Aspirin
- bivalirudin
|
Topics |
- Adult
- Aged
- Angina, Unstable
(drug therapy)
- Aspirin
(therapeutic use)
- Coronary Angiography
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Hirudin Therapy
- Hirudins
(administration & dosage, adverse effects, analogs & derivatives)
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(mortality)
- Myocardial Ischemia
(blood, drug therapy)
- Myocardial Revascularization
- Peptide Fragments
(administration & dosage, adverse effects, therapeutic use)
- Pilot Projects
- Recombinant Proteins
(administration & dosage, adverse effects, therapeutic use)
- Thrombin
(antagonists & inhibitors)
|