Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT03551756
Eligibility Criteria:
Inclusion Criteria:
Group 1: Heart Failure with Coronary Artery Disease Subjects
* Symptomatic heart failure (≥ 3 months) with most recently documented LVEF ≤ 40% (Echo must have been completed in last 12 months prior to enrollment.)
* Significant underlying coronary artery disease as evidenced by:
* previous myocardial infarction
* prior coronary artery bypass graft
* 50% coronary stenosis of one or more arteries and/or
* history of percutaneous coronary intervention with or without stenting
* Age 18 years or older at the first screening visit
Group 2: Healthy Subjects
• Age 18 years or older at the first screening visit and within 20% of mean age of Group 1 Subjects
Exclusion Criteria:
Group 1:
* Documented history of "severe" valvular disease
* Documented history of atrial fibrillation, ventricular fibrillation or ventricular tachycardia.
* Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
Group 2:
* Known significant cardiovascular or hematological condition
* Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
* Recent cold or flu symptoms, respiratory infection or surgery (within 2 weeks of screening)
* History of Asthma
* History of peptic ulcers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03551756
Study Brief:
Protocol Section:
NCT03551756