NCT00128414

Brief Summary

The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_3

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

August 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 16, 2011

Status Verified

February 1, 2011

Enrollment Period

3.7 years

First QC Date

August 8, 2005

Last Update Submit

February 14, 2011

Conditions

PericarditisRecurrence

Keywords

PericarditisRecurrenceTherapeuticsPreventionColchicine

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate at 18 months

Secondary Outcomes (4)

  • Symptom persistence at 72 hours, remission rate at 1 week

  • Number of recurrences

  • Time to recurrence

  • Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo

Colchicine

EXPERIMENTAL

Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients \<70 kg or intolerant to the highest dose.

Drug: Colchicine (for 6 months)

Interventions

Colchicine (for 6 months)DRUG

colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients \<70 kg or intolerant to the highest dose.

Colchicine
PlaceboDRUG

Tablets identical in colour, shape, and taste were provided in blister packs.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with the first 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Internal Medicine Dpt. Ospedali Riuniti

Bergamo, Bergamo, Italy

Location

Department of Cardiology, San Maurizio Regional Hospital

Bolzano, Bolzano, Italy

Location

Cardiology Dpt. Ospedale SS Annunziata

Savigliano, CN, Italy

Location

Cardiology Department. Maria Vittoria Hospital. ASL3 Torino

Torino, Torino, 10141, 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, Brucato A, Cemin R, Ferrua S, Belli R, Maestroni S, Trinchero R, Spodick DH, Adler Y; CORP (COlchicine for Recurrent Pericarditis) Investigators. Colchicine for recurrent pericarditis (CORP): a randomized trial. Ann Intern Med. 2011 Oct 4;155(7):409-14. doi: 10.7326/0003-4819-155-7-201110040-00359. Epub 2011 Aug 28.

    PMID: 21873705DERIVED

MeSH Terms

Conditions

PericarditisRecurrence

Interventions

ColchicineWW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsShort Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Rita TRINCHERO, MD

    Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino

    STUDY CHAIR

  • Massimo Imazio, MD

    Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.

    STUDY CHAIR

  • Massimo Imazio, MD

    Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 10, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2009

Study Completion

October 1, 2010

Last Updated

February 16, 2011

Record last verified: 2011-02

Locations

IT(5)