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.

A pilot study will be conducted in patients older than 18 years with a diagnosis of rheumatoid arthritis in the Hospital Central "Dr. Ignacio Morones Prieto", these patients will be evaluated by the rheumatologist and the patients with and patients with severe activity according of the Disease Activity Score 28 (DAS 28> 5.1) will be invited to their recruitment, a history of ischemic heart disease, heart failure or chronic kidney disease will be reviewed for its exclusion. This is a randomized controlled clinical trial blinded to the rheumatologist and the cardiologist who will carry out the evaluation of the patient. Patients who meet the aforementioned criteria, will be given informed consent to be signed, if accepted and signed, treatment will be given according to block randomization performed as follows: atorvastatin 40 mg orally every 24 hours for four weeks, colchicine with one initial dose of 0.25 mg every 8 hours titrating dose in the first 3 days according to tolerance up to 0.5 mg every 8 hours for four weeks.

A high-sensitivity troponin I measurement will be taken by means of a peripheral blood sample, the echocardiogram will be evaluated by the cardiologist, patients with heart failure will be eliminated with an unknown left ventricular ejection fraction or unknown ischemic heart disease and will be diagnosed at the first echocardiogram. We will review the laboratory studies of the evaluation with rheumatology: blood biometry, lipid profile, anti-citrullinated antibodies, rheumatoid factor, serum creatinine, uric acid, serum glucose. Patients from the area of rheumatology will be reviewed daily to recruit patients who meet the inclusion criteria, the patient will be informed in addition to signing the informed consent in case of accepting. The evaluation of the activity of the disease will be carried out using the DAS 28 scale at the beginning and end of the treatment. Follow up by telephone every week to patient for information of treatment follow-up and adverse effects. When reporting adverse effects with colchicine doses, the dose will be minimally tolerated or discontinued if necessary, as with treatment with atorvastatin. Peripheral blood samples for high sensitivity troponin I will be taken at the end of the four weeks, in addition to an echocardiogram in case of finding alterations in the first evaluation through this study. The changes in this cardiac biomarker and echocardiographic findings of said pilot study will be analyzed with the appropriate methods for this, their differences and statistical significance.

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 (DAS 28> 5.1). Patients are randomized by means of a web-based procedure with a permuted-block design according to trial center. Patients are assigned in a 1:1 ratio to receive atorvastatin 40 mg orally every 24 hours for four weeks or 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.

Secondary end points are the evaluation of findings found in echocardiography in patients with rheumatoid arthritis with severe activity before and after treatment with atorvastatin or colchicine according to randomization and the evaluate the risk factors associated with a higher elevation high sensitivity troponin I in patients with rheumatoid arthritis.

Universe of study. Patients with rheumatoid arthritis older than 18 years with activity of the disease according to DAS 28> 5.1 attended in the rheumatology service of the Central Hospital "Dr. Ignacio Morones Prieto", San Luis Potosi, San Luis Potosi, Mexico.