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

August 8, 2005
June 6, 2012
August 2005
June 2012   (final data collection date for primary outcome measure)
Recurrence rate at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Recurrence rate at 18 months
Complete list of historical versions of study NCT00128453 on ClinicalTrials.gov Archive Site
  • 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 ]
Symptom persistence at 72 hours, remission rate at 1 week. Number of recurrences. Time to first recurrence. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study. Cost-efficacy analyses.
Not Provided
Not Provided
 
Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pericarditis
  • Drug: Colchicine (for 3 months)
    Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily
  • Drug: Placebo
    placebo
  • Placebo Comparator: Placebo
    Conventional therapy plus placebo
    Intervention: Drug: Placebo
  • Active Comparator: Colchicine
    Conventional therapy plus colchicine
    Intervention: Drug: Colchicine (for 3 months)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00128453
DCASL30501-1, EUDRACT number 2005-001570-28
Not Provided
Azienda Sanitaria Locale 3, Torino
Azienda Sanitaria Locale 3, Torino
Not Provided
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.
Azienda Sanitaria Locale 3, Torino
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP