Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

June 6, 2012 updated by: Azienda Sanitaria Locale 3, Torino

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis

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.

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 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 Type

Interventional

Enrollment (Actual)

240

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 Division
      • Bolzano, Italy
        • Cardiology Department-Ospedale Regionale
      • Rivoli, Italy
        • Ospedale di Rivoli
    • Torino
      • Torino., Torino, Italy, 10141
        • Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate at 18 months
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptom persistence at 72 hours, remission rate at 1 week
Time Frame: 1 week
1 week
Number of recurrences
Time Frame: 18 months
18 months
Time to first recurrence
Time Frame: 18 months
18 months
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
Time Frame: 18 months
18 months

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. 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.

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)

June 1, 2012

Study Completion (Actual)

June 1, 2012

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)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCASL30501-1
  • 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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