Trial intelligence / Profile preview

Colchicine in acute pericarditis (ICAP)

NCT00128453Phase 3

Key facts

Status: Completed
Start: Aug 2005
Primary completion: Jun 2012
Countries: 1
Sponsor: ASL TO3
Modality: Nucleic Acid-Directed Small Molecules, Classical Binding Small Molecules, Metabolically Activated Prodrugs

Drugs: colchicine
Conditions: acute pericarditis

Overview

Phase 3, randomised, double-blind trial in acute pericarditis comparing Colchicine with Placebo (2 arms). Primary endpoint: Recurrence rate at 18 months. Started Aug 2005; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Colchicine
Colchicine (0.5mg BID or QD) + Conventional Therapy (Aspirin/Ibuprofen)
Placebo
Placebo + Conventional Therapy (Aspirin/Ibuprofen)

Who it enrols

Adult patients with a first episode of acute pericarditis (index attack).

Endpoints

Primary

Recurrence rate at 18 months18 months

Secondary

Symptom persistence at 72 hours72 hours
Remission rate at 1 week1 week
Number of recurrences18 months
Time to first recurrence18 months
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis18 months

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