- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354376
Replication of the TRANSCEND Antihypertensive Trial in Healthcare Claims Data
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02120
- Brigham and Women's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of telmisartan or a comparator drug (cohort entry).
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Loop diuretics, thiazides, dihydropyridines
Reference group
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Loop diuretics, thiazides, or dihydropyridines dispensing claim is used as the reference
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Telmisartan
Exposure group
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Telmisartan dispensing claim is used as the exposure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality
Time Frame: Through study completion (a median of ***118-123**** days)
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Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality - Please refer to uploaded protocol for full definition due to size limitations.
|
Through study completion (a median of ***118-123**** days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Telmisartan
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Sodium Chloride Symporter Inhibitors
- 1,4-dihydropyridine
Other Study ID Numbers
- 2018P002966-DUP-TRANSCEND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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