Replication of the ONTARGET Antihypertensive Trial in Healthcare Claims Data

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63744 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-22

Study Completion Date

2021-02-08

Brief Summary

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Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

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Detailed Description

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This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ramipril

Reference group

Ramipril

Intervention Type DRUG

Ramipril dispensing claim is used as the reference

Telmisartan

Exposure group

Telmisartan

Intervention Type DRUG

Telmisartan dispensing claim is used as the exposure

Interventions

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Ramipril

Ramipril dispensing claim is used as the reference

Intervention Type DRUG

Telmisartan

Telmisartan dispensing claim is used as the exposure

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No