A Trial of Low-dose Adjunctive alTeplase During prIMary PCI
NCT02257294 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 440
Last updated 2019-09-06
Summary
The purpose of this study is to determine the safety and efficacy of reduced doses (10 mg and 20 mg) of intra-coronary alteplase compared with placebo as an adjunct to PCI in reducing MVO and its consequences in high risk patients with STEMI.
Conditions
Interventions
- DRUG
-
Alteplase
Single treatment consisting of a single slow infusion administration after reperfusion with aspiration thrombectomy ± angioplasty but before stenting during primary PCI.
- OTHER
-
Placebo
Single treatment consisting of a single slow infusion administration after reperfusion with aspiration thrombectomy ± angioplasty but before stenting during primary PCI.
Sponsors & Collaborators
-
University of Glasgow
collaborator OTHER -
National Institute for Health Research, United Kingdom
collaborator OTHER_GOV -
NHS Greater Glasgow and Clyde
lead OTHER
Principal Investigators
-
Colin Berry, Prof · University of Glasgow
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2018-07-31
- Completion
- 2019-05-08
Countries
- United Kingdom
Study Locations
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