Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Pericarditis

Intervention / Treatment
-----------------
* Drug: Colchicine (for 3 months)
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Conventional therapy plus placebo | Drug: Placebo<br>* placebo<br>|
| Active Comparator: Colchicine<br>Conventional therapy plus colchicine | Drug: Colchicine (for 3 months)<br>* Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate at 18 months |  | 18 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine