Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis.

NCT04056039 | Completed Phase 2 DMC

• 1 other identifier: AVSCAR001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study. The primary end point is the evaluation the efficacy of treatment with atorvastatin compared to colchicine for the decrease of high sensitivity troponin I levels in patients with rheumatoid arthritis with severe activity according of the Disease Activity Score 28 (DAS 28\> 5.1), through a randomized controlled clinical trial blinded to the rheumatologist and the cardiologist who will carry out the evaluation of the patient.

Conditions

Cardiovascular Diseases; Arthritis, Rheumatoid

Keywords

rheumatoid arthritis; Troponin I; Atorvastatin; Colchicine; Cardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

• Changes of high sensitivity troponin I levels

  Levels of high sensitivity troponin I in ng / ml with the ARCHITECT STAT Troponin-I assay of high sensitivity by immunoassay by chemo luminescent microparticles, with a calibration range of 0.0-50,000.00 pg / ml.

  It will be evaluated before the start of treatment and at the end of the four weeks of treatment.

Secondary Outcomes (2)

• Changes in echocardiographic findings

  It will be evaluated before the start of treatment and at the end of the four weeks of treatment.

• Risk factors associated with a higher elevation high sensitivity troponin I

  It will be evaluated before the start of treatment

Study Arms (2)

"Atorvastatin"

ACTIVE COMPARATOR

-Changes of troponin I in rheumatoid arthritis with "atorvastatin" 40 mg orally every 24 hours for four weeks

Drug: Atorvastatin

"Colchicine"

ACTIVE COMPARATOR

Changes of troponin I in rheumatoid arthritis with "colchicine" with an initial dose of 0.25 mg every 8 hours, with titration in the first 3 days according to tolerance up to a maximum dose of 0.5 mg every 8 hours for four weeks

Drug: Colchicine

Interventions

Atorvastatin DRUG

Efficacy of atorvastatin 40 mg orally every 24 hours for four weeks vs colchicine with an initial dose of 0.25 mg every 8 hours, with titration in the first 3 days according to tolerance up to a maximum dose of 0.5 mg every 8 hours for four weeks in decrease of troponin I of high sensitivity

"Atorvastatin"

Colchicine DRUG

Efficacy of atorvastatin 40 mg orally every 24 hours for four weeks vs colchicine with an initial dose of 0.25 mg every 8 hours, with titration in the first 3 days according to tolerance up to a maximum dose of 0.5 mg every 8 hours for four weeks in decrease of troponin I of high sensitivity

"Colchicine"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years with a diagnosis of rheumatoid arthritis according to the diagnoses of the American College of Rheumatology and the European League against rheumatism 2010 with severe disease activity according to DAS 28\> 5.1.
• Patients who are accepted according to previous criteria and with signed informed consent.

You may not qualify if:

• Patients with a history of ischemic heart disease.
• Patients with a history of heart failure with decreased left ventricular ejection fraction
• Patients with chronic kidney disease.

Sponsors & Collaborators

• Hospital Central "Dr. Ignacio Morones Prieto": lead

Study Sites (1)

Hospital Central "Dr Ignacio Morones Prieto"

San Luis Potosí City, 78290, Mexico

Location

Related Publications (21)

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MeSH Terms

Conditions

Cardiovascular Diseases; Arthritis, Rheumatoid

Interventions

Atorvastatin; Colchicine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Alkaloids

Study Officials

• Juan M Lopez, MD

  Ethics committee of the Hospital Central "Dr Ignacio Morones Prieto"

  STUDY CHAIR

• Emmanuel Rivera, MD

  Research committee of the Hospital Central "Dr Ignacio Morones Prieto"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Residency

Model Details: A pilot study with 30 patients per group, according to Browne, will be recalculated based on the preliminary result and the power of effect. This is a randomized controlled trial blind to the rheumatologist and the cardiologist who will carry out the evaluation of the patient. The randomization was performed in blocks. Description: Random assignment of n subjects with an equal number in all N conditions can be done by randomizing blocks, where the size of the block is the number of experimental conditions. The number of independent variables and the number of levels in each IV are specified as input. The output is a random design block.

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: August 14, 2019
• Study Start: August 14, 2018
• Primary Completion: June 14, 2019
• Study Completion: June 30, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

ME (1)