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

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ClinicalTrials.gov Identifier: NCT02673879
Recruitment Status : Unknown
Verified February 2016 by Bongani M Mayosi, University of Cape Town.
Recruitment status was:  Recruiting
First Posted : February 4, 2016
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Walter Sisulu University
Population Health Research Institute
Information provided by (Responsible Party):
Bongani M Mayosi, University of Cape Town

Brief 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.

Condition or disease Intervention/treatment Phase
Pericardial Effusion Other: Pericardiocentesis with Alteplase Other: Conventional Pericardiocentesis Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of Complete Percutaneous Pericardial Drainage Facilitated by Intrapericardial Alteplase Compared to Conventional Pericardiocentesis When Indicated in Adults With Large Pericardial Effusion Due to Tuberculous and Non-tuberculous Pericarditis
Study Start Date : February 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Active Comparator: Pericardiocentesis with Alteplase
Complete percutaneous pericardial drainage facilitated by intrapericardial alteplase.
Other: Pericardiocentesis with Alteplase
Complete percutaneous pericardial drainage facilitated by intrapericardial alteplase

Conventional Pericardiocentesis
Conventional pericardiocentesis when indicated.
Other: Conventional Pericardiocentesis
Conventional pericardiocentesis when indicated




Primary Outcome Measures :
  1. Composite outcome of cardiac tamponade requiring pericardiocentesis or constrictive pericarditis. [ Time Frame: 12 months ]

    Cardiac tamponade requiring pericardiocentesis shall refer to a combination of physical and echocardiographic findings, i.e., patients with clinical signs of tachycardia (> 90 bpm), hypotension (systolic blood pressure < 100 mmHg), elevated jugular venous pressure and/or pulsus paradoxus > 10 mmHg plus evidence of a large pericardial effusion with echocardiographic signs of tamponade in the absence of other cardiac disease, as defined in the IMPI trial.

    Constrictive pericarditis shall refer to a combination of physical and echocardiographic findings (i.e., patients with a prior history of pericardial effusion who have pulsus paradoxus, a raised jugular venous pressure with or without evidence of pericardial thickening on imaging) in the absence of either large pericardial effusion or other cardiac disease, as described in the IMPI trial.



Secondary Outcome Measures :
  1. Major bleeding [ Time Frame: 12 months ]
    Defined as clinically overt bleeding accompanied by one or more of the following: a decrease in the haemoglobin level of 2 g per decilitre or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding

  2. Clinically relevant non-major bleeding [ Time Frame: 12 months ]
    Defined as clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to hospital admission, physician-guided medical or surgical treatment.

  3. Any bleeding [ Time Frame: 12 months ]
    Any other form of bleeding that is not covered by safety outcomes 1-3

  4. Other adverse events [ Time Frame: 12 months ]
    Any other adverse events

  5. Persistent pericardial effusion without cardiac tamponade [ Time Frame: 12 months ]
    Refers to the echocardiographic presence of a pericardial effusion without criteria for cardiac tamponade requiring pericarditis during follow-up visits. The pericardial effusion is the same size or larger than that measured at the time of enrollment (where no pericardiocentesis was done) or post-pericardiocentesis.

  6. Recurrent pericardial effusion without cardiac tamponade [ Time Frame: 12 months ]
    Refers to the echocardiographic presence of a pericardial effusion without criteria for cardiac tamponade requiring pericarditis during follow-up visits. Recurrence is present in the context of re-appearance of a pericardial effusion in the context where complete drainage was performed.

  7. Hospitalisation for any cause; and death from any cause [ Time Frame: 12 months ]
    Refers to admission to hospital for at least 24 hours for any reason.

  8. Cardiac tamponade requiring pericardiocentesis [ Time Frame: 12 months ]
    Cardiac tamponade requiring pericardiocentesis shall refer to a combination of physical and echocardiographic findings, i.e., patients with clinical signs of tachycardia (> 90 bpm), hypotension (systolic blood pressure < 100 mmHg), elevated jugular venous pressure and/or pulsus paradoxus > 10 mmHg plus evidence of a large pericardial effusion with echocardiographic signs of tamponade in the absence of other cardiac disease, as defined in the IMPI trial.

  9. Constrictive pericarditis [ Time Frame: 12 months ]
    Constrictive pericarditis shall refer to a combination of physical and echocardiographic findings (i.e., patients with a prior history of pericardial effusion who have pulsus paradoxus, a raised jugular venous pressure with or without evidence of pericardial thickening on imaging) in the absence of either large pericardial effusion or other cardiac disease, as described in the IMPI trial.

  10. Death [ Time Frame: 12 months ]
    Death from any cause


Other Outcome Measures:
  1. Proportion with proven tuberculosis [ Time Frame: 12 months ]
    The proportion with bacteriologically confirmed tuberculosis from any organ or tissue in each group will be based on findings on microscopy, Xpert MRB/RIF, culture, and / histology .

  2. Time to diagnosis of proven tuberculosis [ Time Frame: 12 months ]
    The time to diagnosis of bacteriologically confirmed tuberculosis in days in each group will be based on the date of sample collection and the date of first bacteriological confirmation from any organ or tissue.

  3. Proportion with proven tuberculosis on novel tests who are not put on treatment [ Time Frame: 12 months ]
    The proportion of culture-positive tuberculosis cases who are not placed on treatment in either arm, or the proportion of these which would have been detected by the novel rapid index tests.

  4. Diagnostic accuracy of novel tests of tuberculosis [ Time Frame: 12 months ]
    The diagnostic accuracy of novel tests (e.g., Xpert MTB/RIF, Xpert ULTRA, InterGam) for the detection of culture-positive pericardial tuberculosis (a secondary analysis will be performed using clinically-diagnosed tuberculosis as reference standard)

  5. Drug resistant tuberculosis [ Time Frame: 12 months ]
    The proportion of drug-resistant tuberculosis cases detected.

  6. Specific diagnosis of tuberculous pericarditis [ Time Frame: 12 months ]
    The proportion with a specific diagnosis of pericardial disease in each group will be based on findings on results of investigations for tuberculosis, cancer, purulent pericarditis and other disease.

  7. Time to diagnosis of specific pericardial disease [ Time Frame: 12 months ]
    The time to diagnosis of a specific pericardial disease in days in each group will be based on the date of sample collection and the date of first definitive result.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years of age;
  2. Confirmed large pericardial effusion on echocardiography (i.e., echo free space ≥1 cm anterior to the right ventricle of the heart in diastole);
  3. Willingness to participate for the full duration of the trial (i.e., 12 months); and
  4. Provision of written informed consent.

Exclusion Criteria:

  1. Age < 18 years;
  2. Uraemic pericarditis (i.e., urea > 21.4 mmol/l);
  3. Thrombocytopenia (i.e., < 100,000 platelets per µl);
  4. Presence of a contra-indication to the administration of a fibrinolytic agent (i.e., major haemorrhage or major trauma; coincidental stroke; major surgery in the previous 5 days; blood pressure >200/100 mmHg).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673879


Contacts
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Contact: Veronica Francis +27832449895 veronica.francis@uct.ac.za
Contact: Abolade A Awotedu, MBBS +27822007694 bolaawotedu@gmail.com

Locations
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South Africa
Groote Schuur Hospital Recruiting
Cape Town, Western Cape, South Africa, 7925
Contact: Shaheen Pandie, MMed (Med)    +27823199030    s.pandie@uct.ac.za   
Contact: Veronica Francis    +27832449895    veronica.francis@uct.ac.za   
Sponsors and Collaborators
University of Cape Town
Walter Sisulu University
Population Health Research Institute
Investigators
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Principal Investigator: Bongani M Mayosi, DPhil University of Cape Town
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Responsible Party: Bongani M Mayosi, Professor of Medicine, University of Cape Town
ClinicalTrials.gov Identifier: NCT02673879    
Other Study ID Numbers: HREC REF No. 370/2015
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data will be made available on request at the end of the study, subject to approval by the Steering Committee of the IMPI-2 Trial.
Additional relevant MeSH terms:
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Pericardial Effusion
Heart Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action