NCT00128453

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_3

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

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
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

6.8 years

First QC Date

August 8, 2005

Last Update Submit

June 6, 2012

Conditions

Pericarditis

Keywords

PericarditisRecurrenceTherapeuticsPreventionColchicine

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate at 18 months

    18 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Conventional therapy plus placebo

Drug: Placebo

Colchicine

ACTIVE COMPARATOR

Conventional therapy plus colchicine

Drug: Colchicine (for 3 months)

Interventions

Colchicine (for 3 months)DRUG

Colchicine 0.5mg BID (patients\>70Kg) or 0.5mg once daily

Colchicine
PlaceboDRUG

placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with acute pericarditis (index attack)
  • 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 (4)

Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino

Torino, Torino, 10141, Italy

Location

Internal Medicine Division

Bergamo, Italy

Location

Cardiology Department-Ospedale Regionale

Bolzano, Italy

Location

Ospedale di Rivoli

Rivoli, Italy

Location

Related Publications (2)

  • 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. doi: 10.2459/01.JCM.0000281702.46359.07.

    PMID: 17667033BACKGROUND

  • 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.

    PMID: 23992557DERIVED

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. Italy.

    STUDY CHAIR

  • Massimo IMAZIO, 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

Study Design

Study Type
interventional
Phase
phase 3
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

August 8, 2005

First Posted

August 10, 2005

Study Start

August 1, 2005

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

IT(4)