{"doi":"10.3389/fcvm.2021.728654","title":"Randomized Trial of Anti-inflammatory Medications and Coronary Endothelial Dysfunction in Patients With Stable Coronary Disease","abstract":"Aims: Inflammation plays a critical role in the pathogenesis of coronary artery disease (CAD), however the impact of anti-inflammatory therapies to reduce those processes which promote atherosclerosis in CAD patients is unknown. We aimed to test the hypothesis that anti-inflammatory approaches improve impaired coronary endothelial function (CEF), a driver of coronary atherosclerosis, in stable CAD patients. Methods and Results: We performed a single-center, randomized, placebo-controlled, double-blinded trial to assess whether low dose methotrexate (MTX), low dose colchicine (LDC), and/or their combination (MTX+LDC), improves CEF using non-invasive MRI measures in patients with stable CAD ( N = 94). The primary endpoint was the MRI-detected change in coronary cross-sectional area from rest to isometric handgrip exercise (IHE), a predominantly nitric oxide-dependent endothelial dependent stressor. Coronary and systemic endothelial endpoints, and serum inflammatory markers, were collected at baseline, 8 and 24 weeks. Anti-inflammatory study drugs were well-tolerated. There were no significant differences in any of the CEF parameters among the four groups (MTX, LDC, MTX+LDC, placebo) at 8 or 24 weeks. Serum markers of inflammation and systemic endothelial function measures were also not significantly different among the groups. Conclusion: This is the first study to examine the effects of the anti-inflammatory approaches using MTX, LDC, and/or the combination in stable CAD patients on CEF, a marker of vascular health and the primary endpoint of the study. Although these anti-inflammatory approaches were relatively well-tolerated, they did not improve coronary endothelial function in patients with stable CAD. Clinical Trial Registration: www.clinicaltrials.gov , identifier: NCT02366091.","journal":"Frontiers in Cardiovascular Medicine","year":2021,"id":202901,"datarank":0.4863587307281597,"base_score":1.9459101490553132,"endowment":1.9459101490553132,"self_citation_contribution":0.29188652235829704,"citation_network_contribution":0.19447220836986268,"self_endowment_contribution":0.29188652235829704,"citer_contribution":0.19447220836986268,"corpus_percentile":null,"corpus_rank":null,"citation_count":6,"citer_count":6,"citers_with_citation_signal":6,"citers_with_endowment":6,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9621,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02366091"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":271391,"name":"Michael Schär","orcid":"0000-0002-7044-9941","position":1,"is_corresponding":false},{"id":743736,"name":"Gabriele Bonanno","orcid":"0000-0002-7761-5308","position":2,"is_corresponding":false},{"id":585886,"name":"Shenghan Lai","orcid":"0000-0003-1340-9609","position":3,"is_corresponding":false},{"id":743737,"name":"Joseph Meyer","orcid":"0000-0002-9304-7101","position":4,"is_corresponding":false},{"id":744331,"name":"Yohannes Afework","orcid":null,"position":5,"is_corresponding":false},{"id":300150,"name":"Angela Steinberg","orcid":null,"position":6,"is_corresponding":false},{"id":744333,"name":"Samuel Stradley","orcid":null,"position":7,"is_corresponding":false},{"id":298317,"name":"Gary Gerstenblith","orcid":"0000-0001-6046-6812","position":8,"is_corresponding":false},{"id":271395,"name":"Robert G. Weiss","orcid":"0000-0002-1844-8677","position":9,"is_corresponding":false},{"id":497800,"name":"Allison G. Hays","orcid":"0000-0003-2138-1589","position":0,"is_corresponding":true}],"reference_count":38,"raw_metadata":null,"created_at":"2026-07-18T23:51:14.206397Z","pmid":"34722661","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}