NCT02367976

Efficacy and Safety on Prouk for STEMI Patients in China

A Phase III Study to Research the Efficacy and Safety on Prouk for ST Elevated Mycadial Infarction Patients in China

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Suzhou RxD Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.

Detailed description

The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess percentage of patients achieve the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.

Conditions

• STEMI

Interventions

Type	Name	Description
DRUG	rhprouk	rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2015-02-20
• Last updated: 2015-02-25

Locations

1 site across 1 country: China