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IMPI 2 - A Trial of Intrapericardial Alteplase in Large Pericardial Effusion

NCT02673879 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2176

Last updated 2018-05-02

No results posted yet for this study

Summary

The Second Investigation of the Management of Pericarditis (IMPI-2) Trial will compare the effectiveness and safety of complete percutaneous pericardial drainage facilitated by intrapericardial alteplase (recombinant human tissue-type plasminogen activator) to conventional pericardiocentesis when indicated in 2176 patients with large pericardial effusion due to tuberculous and non-tuberculous pericarditis. An internal pilot study of 218 patients will initially confirm the feasibility of conducting a large-scale multi-centre clinical trial of intrapericardial fibrinolysis in patients with large pericardial effusion, and also provide preliminary safety data, following a dose finding study of intrapericardial alteplase.

Conditions

  • Pericardial Effusion

Interventions

OTHER

Pericardiocentesis with Alteplase

Complete percutaneous pericardial drainage facilitated by intrapericardial alteplase

OTHER

Conventional Pericardiocentesis

Conventional pericardiocentesis when indicated

Sponsors & Collaborators

  • Walter Sisulu University

    collaborator OTHER

  • Population Health Research Institute

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Bongani M Mayosi, DPhil · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-07-31
Completion
2020-01-31

Countries

  • South Africa

Study Locations

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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 NCT02673879 on ClinicalTrials.gov