Prasugrel Or Ticagrelor De-escalation in NSTE-ACS
NCT05779059 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-03-22
Summary
The PROTEUS study is a randomized, cross-over, open-label, pharmacodynamic trial designed to compare the antiplatelet effect of reduced maintenance doses of prasugrel and ticagrelor in stable patients who recently had non-ST-elevation acute coronary syndrome (non-ST-elevation myocardial infarction or unstable angina).
Conditions
- Non ST Segment Elevation Acute Coronary Syndrome
- Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
- Unstable Angina
Interventions
- DRUG
-
De-escalation to ticagrelor 60 mg at day 30
Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.
- DRUG
-
De-escalation to prasugrel 5 mg at day 30
Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.
- DRUG
-
Switch to ticagrelor 60 mg at day 45
Switch to ticagrelor 60 mg bid at day 45.
- DRUG
-
Switch to prasugrel 5 mg at day 45
Switch to prasugrel 5 mg qd at day 45.
Sponsors & Collaborators
-
Collegium Medicum w Bydgoszczy
lead OTHER
Principal Investigators
-
Piotr Adamski, MD, PhD · CM UMK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Poland
Study Locations
More Related Trials
-
Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis
NCT02298088 ·Status: COMPLETED ·Phase: PHASE3
-
A sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients
NCT04307511 ·Status: RECRUITING ·Phase: PHASE4
-
Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.
NCT01226602 ·Status: COMPLETED ·Phase: PHASE1
-
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
NCT01612884 ·Status: TERMINATED ·Phase: PHASE4
-
Ad5FGF-4 In Patients With Refractory Angina Due to Myocardial Ischemia
NCT02928094 ·Status: UNKNOWN ·Phase: PHASE3
-
Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
NCT06577519 ·Status: RECRUITING ·Phase: PHASE3
-
GS-6615 in Adults With Chronic Stable Angina and Coronary Artery Disease
NCT02377336 ·Status: WITHDRAWN ·Phase: PHASE2
-
Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
NCT02284048 ·Status: UNKNOWN ·Phase: PHASE4
-
Rosiglitazone Versus Placebo in Chronic Stable Angina
NCT00225355 ·Status: TERMINATED ·Phase: PHASE4
-
The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina
NCT01763996 ·Status: COMPLETED ·Phase: PHASE4
-
Impact of PCSK9 Inhibitors on Coronary Microvascular Dysfunction in Patients With Atherosclerotic Cardiovascular Disease Proved by Myocardial Ischemia and Needing Coronarography
NCT04338165 ·Status: UNKNOWN ·Phase: PHASE2
-
Rosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance
NCT00733174 ·Status: UNKNOWN ·Phase: PHASE4
-
Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting
NCT02617290 ·Status: COMPLETED ·Phase: PHASE3
-
Offset of Ticagrelor's Effect on Endothelial Function as Assessed With Peripheral Arterial Tonometry (EndoPAT Assay)
NCT01957527 ·Status: COMPLETED
-
A Single Center Study to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response
NCT03027934 ·Status: WITHDRAWN ·Phase: PHASE4
-
Impact of Ticagrelor Re-load on Pharmacodynamic Profiles
NCT01731041 ·Status: COMPLETED ·Phase: NA
-
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
NCT00092677 ·Status: COMPLETED ·Phase: PHASE3
-
Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization
NCT00438867 ·Status: UNKNOWN ·Phase: PHASE3
-
Ticagrelor China Pharmacokinetic/Pharmacodynamic Study
NCT02064985 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina (AGENT-3)
NCT00346437 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
NCT00090714 ·Status: UNKNOWN ·Phase: PHASE2
-
Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention
NCT04999293 ·Status: COMPLETED
-
Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina
NCT02280850 ·Status: UNKNOWN ·Phase: PHASE4
-
Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease
NCT00924157 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
NCT07223593 ·Status: RECRUITING ·Phase: PHASE3