Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier:
NCT00128453
First received: August 8, 2005
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Recurrence rate at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom persistence at 72 hours, remission rate at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Number of recurrences [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Time to first recurrence [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: August 2005
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00128453

Locations
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
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier: NCT00128453     History of Changes
Other Study ID Numbers: DCASL30501-1, EUDRACT number 2005-001570-28
Study First Received: August 8, 2005
Last Updated: June 6, 2012
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 21, 2014