Who is sponsoring NCT02835534?

NCT02835534 is sponsored by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd..

What condition does NCT02835534 study?

NCT02835534 studies Acute ST Elevation Myocardial Infarction.

What drugs are being tested in NCT02835534?

Interventions: rhTNK-tPA, alteplase.

What is the status of NCT02835534?

NCT02835534 is currently COMPLETED.

Last reviewed 2022-05-19 · How we verify

The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute ST Elevation Myocardial Infarction(STEMI): a Multi-center, Randomized, Open, Parallel, Non-inferiority, Active Controlled Trial

NCT02835534 Phase 4 COMPLETED

This study is aiming to test the hypothesis that efficacy of rhTNK-tPA was not inferior to rt-PA with respect to the 30-day MACCE rates after fibrinolytic therapy for STEMI patients. It is a multicenter, randomized, open, parallel, active-controlled, non-inferiority trial.

Details

Lead sponsor	CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Phase	Phase 4
Status	COMPLETED
Enrolment	818
Start date	2016-05
Completion	2020-01

Conditions

Acute ST Elevation Myocardial Infarction

Interventions

rhTNK-tPA
alteplase

Primary outcomes

The proportion of patients with TIMI grade 2 or 3 flow in the infarct-related artery after therapy (Limited to the subgroup for coronary angiography within 24 hours after therapy) — within 24 hours after therapy
A patent IRA was defined as TIMI grade 2 or 3 flow on the angiogram

Countries

China