Efficacy and Safety Evaluation of Recombinant Streptokinase and Urokinase in the Treatment of Pulmonary Embolism: A Multi-Center, Randomized Controlled Trial in China (RESUPEC)

NCT00968929 Phase 4 COMPLETED

Recombinant streptokinase (r-SK) is an effective thrombolytic agent developed with gene engineering. Its characteristics of high output and low production cost make it affordable in treating acute myocardial infarction (AMI) in developing countries. It is unclear whether r-SK can be used in patients with pulmonary embolism (PE). The aim of this study was to investigate the efficacy and safety of 1.5 million IU r-SK by 2 hours infusion and 20,000 IU/kg urokinase (UK) by 2 hours infusion in selected PE patients.

Details

Lead sponsor	Beijing Chao Yang Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	83
Start date	2006-06
Completion	2009-05

Conditions

• Pulmonary Embolism
• Pulmonary Thromboembolism

Interventions

• Recombinant Streptokinase
• Urokinase

Primary outcomes

• The improvement of the right ventricular function on echocardiogram — within the 1st, 14 days and 3 months
• Quantitative computed tomographic pulmonary angiography (CTPA) score — 1st, 14 days and 3 months
• The relief of symptoms — 2-4h, 1st, 4th , 7th, 10th, 14 days day and 3 months

Countries

China