Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03417388
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2018-01-24
Brief Title:
Womens IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Womens IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WARRIOR
Brief Summary:
The Ischemia-IMT Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD subtitle Womens Ischemia Trial to Reduce Events in Non-Obstructive CAD WARRIOR trial is a multicenter prospective randomized blinded outcome evaluation PROBE design evaluating intensive statinACE-I or ARBaspirin treatment IMT vs usual care UC in 4422 symptomatic women patients with symptoms andor signs of ischemia but no obstructive CAD The hypothesis is that IMT will reduce major adverse coronary events MACE 20 vs UC The primary outcome is first occurrence of MACE as death nonfatal MI nonfatal stroketransient ischemic attack TIA or hospitalization for heart failure or angina Secondary outcomes include quality of life time to return to dutywork health resource consumption angina cardiovascular CV death and primary outcome components Events will be adjudicated by an experienced Clinical Events Committee CEC Follow-up will be 3-years using 50 sites primarily VA and Active Duty Military HospitalsClinics and a National Patient-Centered Clinical Research Network PCORnet clinical data research network CDRNOneFlorida Consortium
This study is being conducted to determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms ie chest pain shortness of breath will reduce the patients likelihood of dying having a heart attack strokeTIA or being hospitalized for cardiac reasons The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients and ultimately improve the patients cardiac health and quality of life and reduce health-care costs
This study is being conducted to determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms ie chest pain shortness of breath will reduce the patients likelihood of dying having a heart attack strokeTIA or being hospitalized for cardiac reasons The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients and ultimately improve the patients cardiac health and quality of life and reduce health-care costs
Detailed Description:
WARRIOR trial is a multi-site PROBE design that will evaluate an intensive statinACE-I or ARBaspirin treatment strategy IMT vs primary prevention risk factor therapy treatment strategy UC in 4422 symptomatic chronic angina or equivalent women with non-obstructive CAD 50 diameter narrowing
There will be 80 US sites including VA military and OneFlorida CDRN sites with a proven record in prior trials The investigators will use web-based real-time data entry and management University of Florida Data Management System UFDMS for site selection screening participant eligibility confirmation enrollment and randomization Participants will be recruited from screened women with symptoms suspected to be ischemic with non-obstructive CAD by invasive coronary angiogram or CT angiogram The high dose statin atorvastatin or rosuvastatin and ACE-I lisinopril or ARB losartan are generic commonly used medications previously demonstrated effective for improving angina stress testing myocardial perfusion and coronary microvascular flow reserve in small size trials in this population Additionally aspirin will also be recommended to IMT participants without contraindications or excess bleeding risk however aspirin will not be provided by the study Both the groups will also receive Lifestyle Counseling PACE Assessment and the same visit schedule and face-time with site staff to reduce bias Events will be adjudicated by the Clinical Events Committee CEC according to objective criteria and masked to treatment assignment clues
There will be 80 US sites including VA military and OneFlorida CDRN sites with a proven record in prior trials The investigators will use web-based real-time data entry and management University of Florida Data Management System UFDMS for site selection screening participant eligibility confirmation enrollment and randomization Participants will be recruited from screened women with symptoms suspected to be ischemic with non-obstructive CAD by invasive coronary angiogram or CT angiogram The high dose statin atorvastatin or rosuvastatin and ACE-I lisinopril or ARB losartan are generic commonly used medications previously demonstrated effective for improving angina stress testing myocardial perfusion and coronary microvascular flow reserve in small size trials in this population Additionally aspirin will also be recommended to IMT participants without contraindications or excess bleeding risk however aspirin will not be provided by the study Both the groups will also receive Lifestyle Counseling PACE Assessment and the same visit schedule and face-time with site staff to reduce bias Events will be adjudicated by the Clinical Events Committee CEC according to objective criteria and masked to treatment assignment clues
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-17-2-0030 | OTHER_GRANT | None | None |
| OCR17268 | OTHER | None | None |
| IRB201802734 | OTHER | None | None |
| IRB201701434 | OTHER | UF IRB-01 | None |