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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
Sponsor:
Information provided by (Responsible Party):
José Alfredo Alvarado Alvarado, Hospital Central "Dr. Ignacio Morones Prieto"

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Arthritis, Rheumatoid Drug: Atorvastatin Drug: Colchicine Phase 2

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: "Atorvastatin"
-Changes of troponin I in rheumatoid arthritis with "atorvastatin" 40 mg orally every 24 hours for four weeks
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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Mexico
Hospital Central "Dr Ignacio Morones Prieto"
San Luis Potosí, Mexico, 78290
Sponsors and Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"
Investigators
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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"
  Study Documents (Full-Text)

Documents provided by José Alfredo Alvarado Alvarado, Hospital Central "Dr. Ignacio Morones Prieto":
Statistical Analysis Plan  [PDF] July 25, 2018
Informed Consent Form  [PDF] July 25, 2018

Publications:

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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

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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
Keywords provided by José Alfredo Alvarado Alvarado, Hospital Central "Dr. Ignacio Morones Prieto":
rheumatoid arthritis
Troponin I
Atorvastatin
Colchicine
Cardiovascular disease risk
Additional relevant MeSH terms:
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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