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ACE Inhibitor/ARB

Intensive Cardiovascular Medication for Coronary Artery Disease (WARRIOR Trial)

Phase 4
Waitlist Available
Led By Carl J Pepine, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

WARRIOR Trial Summary

This trial is testing whether intensive treatment with statins, ACE inhibitors, and aspirin can reduce major adverse events in women with coronary artery disease who don't have blockages.

Who is the study for?
This trial is for women with symptoms of ischemia (like chest pain) and non-obstructive coronary artery disease, which means their heart arteries are not severely narrowed. They should have had a cardiac evaluation within the last 5 years and be willing to consent to the study. Women who are pregnant or have serious heart conditions, severe kidney disease, or a recent stroke aren't eligible.Check my eligibility
What is being tested?
The WARRIOR trial tests whether intensive medical treatment with statins, ACE inhibitors (or ARBs), and aspirin can reduce major adverse coronary events in women compared to usual care. It's a randomized study where outcomes like heart attacks and quality of life will be tracked over three years.See study design
What are the potential side effects?
Possible side effects include coughing or elevated blood potassium levels from ACE-I/ARBs; bleeding risks from aspirin; muscle pain or weakness from high-dose statins; as well as potential liver issues also related to statins.

WARRIOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All Cause Death incidents reported between the two groups
Cardiovascular Diseases
Hospitalizations for heart failure incidents reported between the two groups
+2 more

WARRIOR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive Medical Treatment (IMT)Experimental Treatment5 Interventions
The IMT-assigned women will receive high dose potent statin, and moderate dose of an ACE-I (lisinopril) or ARB (losartan). Aspirin will also be recommended to IMT women without contraindications or bleeding risk. This group will also receive Lifestyle Counseling (PACE Assessment), Quality of Life questionnaires, and the same visit schedule and "face-time" with site staff to reduce bias.
Group II: Usual Care (UC)Active Control1 Intervention
The UC-assigned women will maintain standard of care. This group will also receive Lifestyle Counseling (PACE Assessment), Quality of Life questionnaires, and the same visit schedule and "face-time" with site staff to reduce bias.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality of Life Questionnaires
2005
Completed Phase 4
~1380
Acetylsalicylic acid
FDA approved
Lifestyle Counseling
2011
Completed Phase 2
~7440

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
861 Previous Clinical Trials
224,718 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
68 Patients Enrolled for Coronary Artery Disease
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
713,229 Total Patients Enrolled
44 Trials studying Coronary Artery Disease
27,674 Patients Enrolled for Coronary Artery Disease
Carl J Pepine, MDPrincipal InvestigatorUniversity of Florida
5 Previous Clinical Trials
22,376 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
22,148 Patients Enrolled for Coronary Artery Disease

Media Library

ACE-I (lisinopril) or ARB (losartan) (ACE Inhibitor/ARB) Clinical Trial Eligibility Overview. Trial Name: NCT03417388 — Phase 4
Coronary Artery Disease Research Study Groups: Intensive Medical Treatment (IMT), Usual Care (UC)
Coronary Artery Disease Clinical Trial 2023: ACE-I (lisinopril) or ARB (losartan) Highlights & Side Effects. Trial Name: NCT03417388 — Phase 4
ACE-I (lisinopril) or ARB (losartan) (ACE Inhibitor/ARB) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03417388 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the qualifications for participation in this experiment?

"This clinical trial is seeking 4,422 patients with coronary artery disease aged between 18 and 100. In order to apply for consideration, participants must demonstrate symptoms of suspected ischemia prompting referral for further evaluation by cardiac catheterization or coronary angiogram/CT angiogram within 5 years from their consent date; additionally they need to agree to provide written informed permission and have non-obstructive CAD (0-49% diameter reduction in a major epicardial vessel) or FFR > 0.80 ."

Answered by AI

Could you elaborate on any precedent set by prior experiments using ACE-I (lisinopril) or ARB (losartan)?

"In 2005, Vermont Cancer Center first began researching the application of ACE-I (lisinopril) or ARB (losartan). Since then, a total of 1505 clinical trials have been concluded. Currently 290 medical studies are still running, with many conducted in New york City."

Answered by AI

Is the FDA's stamp of approval applicable to lisinopril or losartan?

"The therapeutic potential of ACE-I (lisinopril) and ARB (losartan) has been confirmed in Phase 4 trials, representing a score of 3 on the safety scale."

Answered by AI

Are individuals aged 55 years and older eligible for this research?

"This trial has specified that eligible participants must be between 18 and 100 years old. 73 studies are available for those younger than 18, while 1123 are open to individuals above the age of 65."

Answered by AI

Are there any opportunities currently available to participate in this research?

"Affirmative. According to the information found on clinicaltrials.gov, this medical study is currently enrolling participants. It was first published on February 9th 2018 and last updated on September 14th 2021; a total of 4422 individuals are needed from 86 sites for completion of the trial."

Answered by AI

At how many distinct facilities is this clinical trial administered?

"As evidenced by the list of 87 clinical trial sites, NYU Langone in New york City, Baptist Health in Jacksonville, Georgia and Advent Sebring in Sebring Mississippi are included among those offering this medication."

Answered by AI

What conditions commonly necessitate the prescription of ACE-I (lisinopril) or ARB (losartan)?

"Lisinopril and losartan are commonly used to medicate coronary heart disease. These drugs may also help treat synovitis, anxiety, and other conditions related to the re-narrowing of a coronary artery."

Answered by AI

What is the current threshold for enrollment into this research project?

"In order to satisfy the predetermined criteria of this research, approximately 4422 participants are needed. Patients can apply at NYU Langone in New york City or Baptist Health in Jacksonville, Georgia."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
Family Medicine at Hampton Oaks Medical Plaza (Adults and Peds)
UF Primary Care at Lake City West
Ocala Research Institute Inc.
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
~157 spots leftby Sep 2024