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Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode) (CORP)

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ClinicalTrials.gov Identifier: NCT00128414
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : February 16, 2011
Sponsor:
Information provided by:
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 and prevention of recurrent pericarditis (first episode).

Condition or disease Intervention/treatment Phase
Pericarditis Recurrence Drug: Colchicine (for 6 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 first attack of recurrent pericarditis and the prevention of further recurrences.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Pericarditis
Study Start Date : August 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : October 2010

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
Placebo Comparator
 Drug: Placebo
Tablets identical in colour, shape, and taste were provided in blister packs.
Experimental: Colchicine
Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.
 Drug: Colchicine (for 6 months)
colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence rate at 18 months

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

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 the first attack of recurrent pericarditis
  • 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): NCT00128414


Locations
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Italy
Cardiology Dpt. Ospedale SS Annunziata
Savigliano, CN, Italy
Internal Medicine Dpt. Ospedali Riuniti
Bergamo, Italy
Department of Cardiology, San Maurizio Regional Hospital
Bolzano, Italy
Ospedale di Rivoli
Rivoli, Italy
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino
Torino, Italy, 10141
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
Study Chair: Massimo Imazio, MD Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
Principal Investigator: Massimo Imazio, MD Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
More Information
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Publications:

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

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ClinicalTrials.gov Identifier: NCT00128414    
Other Study ID Numbers: DCASL30501-2
EUDRACT number 2005-001570-28
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: February 16, 2011
Last Verified: February 2011
Keywords provided by Azienda Sanitaria Locale 3, Torino:
Pericarditis
Recurrence
Therapeutics
Prevention
Colchicine
Additional relevant MeSH terms:
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Pericarditis
Recurrence
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Colchicine
 Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents