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

February 14, 2011 updated by: Azienda Sanitaria Locale 3, Torino

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Pericarditis

The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy
        • Internal Medicine Dpt. Ospedali Riuniti
      • Bolzano, Italy
        • Department of Cardiology, San Maurizio Regional Hospital
      • Rivoli, Italy
        • Ospedale di Rivoli
      • Torino, Italy, 10141
        • Cardiology Department. Maria Vittoria Hospital. ASL3 Torino
    • CN
      • Savigliano, CN, Italy
        • Cardiology Dpt. Ospedale SS Annunziata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Recurrence rate at 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (ESTIMATE)

August 10, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 14, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCASL30501-2
  • EUDRACT number 2005-001570-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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