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

NCT02673879 | Unknown Phase 3 DMC

• 1 other identifier: HREC REF No. 370/2015
• Study Type: interventional
• Target: 2,176
• Locations: 1 country
• Sites: 1

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.

Conditions

Pericardial Effusion

Outcome Measures

Primary Outcomes (1)

• Composite outcome of cardiac tamponade requiring pericardiocentesis or constrictive pericarditis.

  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.

  12 months

Secondary Outcomes (10)

• Major bleeding

  12 months

• Clinically relevant non-major bleeding

  12 months

• Any bleeding

  12 months

• Other adverse events

  12 months

• Persistent pericardial effusion without cardiac tamponade

  12 months

Other Outcomes (7)

• Proportion with proven tuberculosis

  12 months

• Time to diagnosis of proven tuberculosis

  12 months

• Proportion with proven tuberculosis on novel tests who are not put on treatment

  12 months

Study Arms (2)

Pericardiocentesis with Alteplase

ACTIVE COMPARATOR

Complete percutaneous pericardial drainage facilitated by intrapericardial alteplase.

Other: Pericardiocentesis with Alteplase

Conventional Pericardiocentesis

OTHER

Conventional pericardiocentesis when indicated.

Other: Conventional Pericardiocentesis

Interventions

Pericardiocentesis with Alteplase OTHER

Complete percutaneous pericardial drainage facilitated by intrapericardial alteplase

Pericardiocentesis with Alteplase

Conventional Pericardiocentesis OTHER

Conventional pericardiocentesis when indicated

Conventional Pericardiocentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age \< 18 years;
• Uraemic pericarditis (i.e., urea \> 21.4 mmol/l);
• Thrombocytopenia (i.e., \< 100,000 platelets per µl);
• 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).

Sponsors & Collaborators

• University of Cape Town: lead
• Walter Sisulu University: collaborator
• Population Health Research Institute: collaborator

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

RECRUITING

MeSH Terms

Conditions

Pericardial Effusion

Interventions

Pericardiocentesis; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Investigative Techniques; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Bongani M Mayosi, DPhil

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Francis

CONTACT

+27832449895; veronica.francis@uct.ac.za

Abolade A Awotedu, MBBS

CONTACT

+27822007694; bolaawotedu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 2, 2018

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)