NCT02495012

Anfibatide Treatment in STEMI Patients

A Multi-centered, Randomized, Double-blinded, Placebo-Parallel Controlled Phase IIb Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin Injection for the Treatment of Patients With ST Segment Elevation Myocardial Infarction (STEMI) Before Receiving PCI Therapy.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.

Detailed description

Anfibatide is a snake venom, and we have investigated it in humans for many years with phase 1\&2a studies. A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.

Conditions

• ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	placebo	Freeze-dried powder without snake venom will be dissovled in saline
DRUG	Anfibatide	Freeze-dried powder with snake venom will be dissovled in saline

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2015-07-13
• Last updated: 2015-07-13

Locations

1 site across 1 country: China