Pharmacoinvasive Therapy With Prourokinase

Suzhou Landing Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Treatments: Drug: Prourokinase; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01642667

PROUK

Details and patient eligibility

About

The aim of this study is to elucidate the efficacy and safety of pharmacoinvasive therapy by using prourokinase (prouk), a unique fibrin-specific agent, in patients with ST-segment elevation myocardial infarction (STEMI)

Enrollment: 197 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 75 years or younger, symptom onset 6 h or less before randomization, intention to undertake primary PCI, ST-segment elevation of 2 mm or more in two anterior leads or of 1 mm or more in two inferior leads if they had ST-segment elevation, or new left bundle-branch block.

Exclusion criteria

• expected arrival at the catheterization laboratory less than 1 h or more than 3 h after randomization, anticipated problems with vascular access, previous enrollment to other studies, and the usual contraindications to thrombolytic therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 2 patient groups, including a placebo group

primary PCI

Placebo Comparator group

Treatment:

Drug: Placebo

prouk-PCI

Active Comparator group

Treatment:

Drug: Prourokinase