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Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128453
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Azienda Sanitaria Locale 3, Torino

Study Description
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Brief Summary:
The purpose of the study is to determine whether colchicine is safe and effective in the treatment of acute pericarditis and the prevention of subsequent recurrences.

Condition or disease Intervention/treatment Phase
Pericarditis Drug: Colchicine (for 3 months) Drug: Placebo Phase 3

Detailed Description:

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the index attack of pericarditis and the prevention of further recurrences.

Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences. Colchicine will be used in addition to conventional treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis
Study Start Date : August 2005
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Conventional therapy plus placebo
 Drug: Placebo
placebo
Active Comparator: Colchicine
Conventional therapy plus colchicine
 Drug: Colchicine (for 3 months)
Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence rate at 18 months [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Symptom persistence at 72 hours, remission rate at 1 week [ Time Frame: 1 week ]
  2. Number of recurrences [ Time Frame: 18 months ]
  3. Time to first recurrence [ Time Frame: 18 months ]
  4. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study [ Time Frame: 18 months ]

Eligibility Criteria
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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:

  • Patients with acute pericarditis (index attack)
  • Age≥ 18 years
  • Informed consent

Exclusion Criteria:

  • Suspected neoplastic, tuberculous, or purulent etiology
  • Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality
  • Serum creatinine >2.5 mg/dl
  • Serum creatine kinase (CK) over the upper limit of normality or known myopathy
  • Known gastrointestinal or blood disease
  • Pregnant or lactating women or women not protected by a contraception method
  • Known hypersensibility to colchicine
  • Treatment with colchicine at enrolment
Contacts and Locations
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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): NCT00128453


Locations
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Italy
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino
Torino., Torino, Italy, 10141
Internal Medicine Division
Bergamo, Italy
Cardiology Department-Ospedale Regionale
Bolzano, Italy
Ospedale di Rivoli
Rivoli, Italy
Sponsors and Collaborators
Azienda Sanitaria Locale 3, Torino
Investigators
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Study Chair: Rita TRINCHERO, MD Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Study Chair: Massimo IMAZIO, MD Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Principal Investigator: Massimo IMAZIO, MD Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier: NCT00128453    
Other Study ID Numbers: DCASL30501-1
EUDRACT number 2005-001570-28
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
Keywords provided by Azienda Sanitaria Locale 3, Torino:
Pericarditis
Recurrence
Therapeutics
Prevention
Colchicine
Additional relevant MeSH terms:
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Pericarditis
Heart Diseases
Cardiovascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents