Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences - Full Text View

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:

MedlinePlus related topics: Pericardial Disorders

Drug Information available for: Colchicine

U.S. FDA Resources

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 (Adult, Senior)
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:

Imazio M, Cecchi E, Ierna S, Trinchero R; ICAP Investigators. Investigation on Colchicine for Acute Pericarditis: a multicenter randomized placebo-controlled trial evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of pericarditis; study design amd rationale. J Cardiovasc Med (Hagerstown). 2007 Aug;8(8):613-7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Beqaraj F, Demarie D, Forno D, Ferro S, Maestroni S, Belli R, Trinchero R, Spodick DH, Adler Y; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. doi: 10.1056/NEJMoa1208536. Epub 2013 Aug 31.


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 Heart Diseases Cardiovascular Diseases Colchicine Gout Suppressants Antirheumatic Agents	Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on September 27, 2016