NCT01585259

Anfibatide Phase Ib-IIa Clinical Trial

A Multi-center, Randomized, Double-blind, Multi-dose Group, Parallel Group and Placebo Controlled Phase Ib-IIa Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin for Injection for the Treatment of Patients With Non-ST Segment Elevation Myocardial Infarction (NSTEMI).

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction patients

Detailed description

1. This study is a phase Ib-IIa exploratory study to observe the safety of Antiplatelet Thrombolysin for Injection for the treatment of non-ST segment myocardial infarction (NSTEMI) patients and preliminarily evaluate the efficacy of different doses, providing the theoretical basis of the phase II and III clinical study protocol. 2. To investigate the pharmacokinetics of different doses.

Conditions

• Non-ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Anfibatide	Snake venom
DRUG	Placebo	Saline

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-12-01
• Completion: 2015-07-01
• First posted: 2012-04-25
• Last updated: 2021-07-14

Locations

1 site across 1 country: China