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

This study has been completed.
Sponsor:
Information provided by:
Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier:
NCT00128414
First received: August 8, 2005
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Pericarditis
Recurrence
Drug: Colchicine (for 6 months)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Azienda Sanitaria Locale 3, Torino:

Primary Outcome Measures:
  • Recurrence rate at 18 months

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

Estimated Enrollment: 120
Study Start Date: August 2005
Study Completion Date: October 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128414

Locations
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
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

Publications:
ClinicalTrials.gov Identifier: NCT00128414     History of Changes
Other Study ID Numbers: DCASL30501-2, EUDRACT number 2005-001570-28
Study First Received: August 8, 2005
Last Updated: February 14, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Sanitaria Locale 3, Torino:
Pericarditis
Recurrence
Therapeutics
Prevention
Colchicine

Additional relevant MeSH terms:
Pericarditis
Recurrence
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Colchicine
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014