Phase 2
N=94
Inflammation and Coronary Endothelial Function
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02366091 ↗Enrolled (actual)
94
Serious AEs
6.4%
Results posted
Oct 2021
Primary outcome: Primary: Percent Change in Coronary Cross Sectional Area (CSA) From Rest to That During Isometric Handgrip Exercise (IHE) — -1.70; 2.71; -0.39; 2.04 Percent change from rest measurement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methotrexate (Drug); Colchicine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Coronary Cross Sectional Area (CSA) From Rest to That During Isometric Handgrip Exercise (IHE) |
1.94; -5.39; 2.64; 9.26 | — |
| SECONDARY Percent Change in Coronary Cross Sectional Area (CSA) From Rest to That During Isometric Handgrip Exercise (IHE) |
1.94; -5.39; 2.64; 9.26 | — |
| SECONDARY Percent Change in Coronary Blood Flow (CBF), Measured by MRI as the Change From Rest to IHE Stress |
10.23; 14.06; 12.38; 13.81 | — |
| SECONDARY Serum High-sensitivity C Reactive Protein (Hs-CRP) |
2.40; 3.10; 1.45; 1.65 | — |
| SECONDARY Serum Interleukin-6 (IL-6) |
1.61; 1.20; 0.83; 0.92 | — |
| SECONDARY Brachial Flow Mediated Dilation (FMD) |
4.37; 3.23; 3.58; 4.57 | — |
Summary
The investigators are studying whether anti-inflammatory agents can improve abnormal coronary artery function in patients with coronary artery disease (CAD) and abnormal coronary artery endothelial function.
Eligibility Criteria
Inclusion Criteria
- Participants of either gender who are 21 years of age (no upper age limit),
- History of prior Myocardial Infarction (MI), coronary revascularization, or coronary angiography or Multidetector Computer Tomography (MDCT) demonstrating at least one coronary artery with >50% luminal stenosis and no plans for revascularization,
- Clinically stable for 3 months,
- Vascular inflammation based on elevated hsCRP (>2mg L-1), or a clinical diagnosis of diabetes mellitus or metabolic syndrome (metabolic syndrome is defined by three or more of the following): Abdominal obesity (waist circumference: Men>102 cm (>40 in), Women >88 cm (>35 in)), Serum triglycerides ≥150 mg/dL (or taking medication to treat high triglycerides), HDL cholesterol: Men 2x upper limit of normal), hepatitis B or C, moderate renal disease (estimated creatine clearance <45ml/min), or planned surgery,
- Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease,
- Interstitial lung disease or pulmonary fibrosis,
- HIV positive,
- Requirement for, or intolerance to, methotrexate or colchicine ,
- Intolerance to methotrexate, colchicine or folate,
- History of non-basal cell malignancy or treatment for lymphoproliferative disease in the past 5 years,
- Requirement for use of drugs that alter folate metabolism,
- History of alcohol abuse or unwillingness to limit consumption to < 4 drinks per week,
- Women of childbearing potential or intention to breastfeed.
- Men who plan to father children during the study period; men who have sexual intercourse with women of childbearing potential must agree to use a condom,
- Chronic use of oral or IV steroid therapy or other immunosuppressive or biologic response modifiers,
- History of chronic pericardial effusion, pleural effusion or ascites,
- New York Heart Association Class IV heart failure.
Data sourced from ClinicalTrials.gov (NCT02366091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.