CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Atorvastatin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04056039
NCT04056039Phase 2Completed

Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity.

Hospital Central "Dr. Ignacio Morones Prieto"·interventional·Posted Aug 14, 2019·Updated Aug 14, 2019

In Brief

A Phase 2 clinical trial evaluating Atorvastatin and Colchicine for Cardiovascular Diseases and Arthritis, Rheumatoid. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2019
Enrollment StartAug 14, 2018
Primary CompletionJun 14, 2019
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.9 years ago

Interventions

Atorvastatindrug

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

Colchicinedrug

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