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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

Approved for 30 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All Cause Death incidents reported between the two groups

Cardiovascular Diseases

Hospitalizations for heart failure incidents reported between the two groups

+2 more

Awards & Highlights

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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