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 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT04354350
Eligibility Criteria:
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Eligible cohort entry dates: Market availability of telmistartan in the U.S. started on November 10, 1998, however, the Marketscan and Optum data are available at BWH only from Jan 1, 2003 and Jan 1, 2004, respectively. For Marketscan: Jan 1, 2003 -Dec 2017 (end of data availability). For Optum: Jan 1, 2004-June 30, 2019 (end of data availability).
Inclusion Criteria:
* Individuals 55 years of age with 1 of the following:
* 1\. Coronary artery disease
* 1a. Previous myocardial infraction ( \> 2 days post uncomplicated MI)
* 1b. Stable angina or unstable angina \> 30 days before informed consent and with documented evidence of multivessel coronary artery disease
* 1c. Multi-vessel PTCA \>30 days before informed consent
* 1d. Multi-vessel CABG surgery \> 4 years before informed consent, or with recurrent angina following surgery
* 2\. Peripheral artery disease
* 2a. Previous limb bypass surgery or Previous limb bypass surgery or angioplasty
* 2b. Previous limb or foot amputation
* 2c. Intermittent claudication, with ankle:arm BP ratio =\< 0.80 on at least 1 side
* 2d. Significant peripheral artery stenosis ( \> 50%) documented by angiography or non-invasive testing
* 3\. Cerebrovascular disease
* 3a. Previous stroke
* 3b. Transient ischemic attacks \>7 days and \<1 year before informed consent
* 4\. Diabetus mellitus
* 4a. Diabetes mellitus High-risk diabetics with evidence of endorgan damage
Exclusion Criteria:
* 1\. Medication use
* 1a. Inability to discontinue ACE inhibitors or ARB
* 1b. Known hypersensitivity or intolerance to ACE inhibitors or ARB (patient intolerant of ACE inhibitor can be enrolled in TRANSCEND)
* 2\. Cardiovascular disease (HF)
* 2a. Symptomatic congestive heart failure
* 2b. Hemodynamically significant primary valvular or outflow tract obstruction
* 2c. Constrictive pericarditis
* 2d. Complex congenital heart disease
* 2e. Syncopal episodes of unknown etiology \<3 months before informed consent
* 2f. Planned cardiac surgery or PTCA \<3 months of informed consent
* 2g. Uncontrolled hypertension on treatment (eg, BP \>160/100 mm Hg)
* 2f. Heart transplant recipient
* 2g. Stroke due to subarachnoid hemorrhage
* 3\. Other conditions
* 3a. Significant renal artery disease
* 3b. Hepatic dysfunction
* 3c. Uncorrected volume or sodium depletion
* 3d. Primary hyperaldosteronism
* 3e. Hereditary fructose intolerance
* 3f. Other major noncardiac illness expected to reduce life expectancy or interfere with study participation
* 3g. Simultaneously taking another experimental drug
* 3h. Significant disability precluding regular follow-up visits
* 3I. Unable or unwilling to provide written informed consent
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT04354350
Study Brief:
Protocol Section:
NCT04354350