A Trial of Low-dose Adjunctive alTeplase During prIMary PCI

NCT02257294 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2019-09-06

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02257294 on ClinicalTrials.gov