Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis. (ACAR1)
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ClinicalTrials.gov Identifier: NCT04056039 |
Recruitment Status :
Completed
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
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Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Diseases Arthritis, Rheumatoid | Drug: Atorvastatin Drug: Colchicine | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | Double (Care Provider, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | 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. |
Actual Study Start Date : | August 14, 2018 |
Actual Primary Completion Date : | June 14, 2019 |
Actual Study Completion Date : | June 30, 2019 |

Arm | Intervention/treatment |
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Active Comparator: "Atorvastatin"
-Changes of troponin I in rheumatoid arthritis with "atorvastatin" 40 mg orally every 24 hours for four weeks
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Drug: Atorvastatin
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 |
Active Comparator: "Colchicine"
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
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Drug: Colchicine
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 |
- Changes of high sensitivity troponin I levels [ Time Frame: It will be evaluated before the start of treatment and at the end of the four weeks of treatment. ]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.
- Changes in echocardiographic findings [ Time Frame: It will be evaluated before the start of treatment and at the end of the four weeks of treatment. ]Changes by echocardiography in patients with alterations found in the initial study after 4 weeks of treatment with a new imaging study.
- Risk factors associated with a higher elevation high sensitivity troponin I [ Time Frame: It will be evaluated before the start of treatment ]Perform statistical analysis with the baseline characteristics of patients to show their association with high levels of high sensitivity troponin I.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056039
Mexico | |
Hospital Central "Dr Ignacio Morones Prieto" | |
San Luis Potosí, Mexico, 78290 |
Study Chair: | 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" |
Documents provided by José Alfredo Alvarado Alvarado, Hospital Central "Dr. Ignacio Morones Prieto":
Responsible Party: | José Alfredo Alvarado Alvarado, Internal Medicine Residency, Hospital Central "Dr. Ignacio Morones Prieto" |
ClinicalTrials.gov Identifier: | NCT04056039 |
Other Study ID Numbers: |
AVSCAR001 |
First Posted: | August 14, 2019 Key Record Dates |
Last Update Posted: | August 14, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
rheumatoid arthritis Troponin I Atorvastatin Colchicine Cardiovascular disease risk |
Arthritis Arthritis, Rheumatoid Cardiovascular Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Colchicine Atorvastatin Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents |