NCT00235079

Brief Summary

The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

6.1 years

First QC Date

October 6, 2005

Last Update Submit

August 6, 2013

Conditions

PericarditisRecurrence

Keywords

PericarditisRecurrenceTherapeuticsPreventionColchicine

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate at 18 months

    18 m onths

Secondary Outcomes (1)

  • Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study.

    1 week

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months

Drug: Colchicine

Placebo

PLACEBO COMPARATOR

Placebo 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months

Drug: Placebo

Interventions

ColchicineDRUG

Colchicine 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months

Colchicine
PlaceboDRUG

Placebo comparator

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with the second and subsequent attack of recurrent pericarditis,
  • Age≥ 18 years,
  • Informed consent.

You may not qualify if:

  • 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 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 the enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center)

Torino, Torino, 10141, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Location

Ospedale Regionale

Bolzano, Italy

Location

Ospedale di Rivoli

Rivoli, Italy

Location

Related Publications (2)

  • Imazio M, Cecchi E, Ierna S, Trinchero R; CORP Investigators. CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale. J Cardiovasc Med (Hagerstown). 2007 Oct;8(10):830-4. doi: 10.2459/JCM.0b013e3280110616.

    PMID: 17885522BACKGROUND

  • Imazio M, Belli R, Brucato A, Cemin R, Ferrua S, Beqaraj F, Demarie D, Ferro S, Forno D, Maestroni S, Cumetti D, Varbella F, Trinchero R, Spodick DH, Adler Y. Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial. Lancet. 2014 Jun 28;383(9936):2232-7. doi: 10.1016/S0140-6736(13)62709-9. Epub 2014 Mar 30.

    PMID: 24694983DERIVED

MeSH Terms

Conditions

PericarditisRecurrence

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Massimo Imazio, MD

    Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)

    STUDY CHAIR

  • Rita Trinchero, MD

    Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

IT(4)