Clinical trial NCT05744804: Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction
Official title: Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient With Anterior Myocardial Infarction
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite the use of guideline directed optimal medical therapy, 12% of patients with stable coronary heart disease and 18% of patients with recent acute coronary syndrome experience recurrent major adverse cardiovascular events 1. The risk of recurrent cardiovascular events may be related to persistent elevation of thrombin beyond the index event 2,3

which leads to progression of cardiovascular disease by inducing inflammation, endothelial dysfunction and thrombosis 4. In patients with coronary heart disease, vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) have been explored as secondary prevention strategies and have shown cardiovascular benefits at the cost of higher bleeding events 5,6,7,8.

howeverLeft ventricular thrombus (LVT) usually appearswithin 1 month after ST-segment elevation myocardial infarction (STEMI) and mostlyforms after anterior STEMI.9,11Although the prevalenceof LVT after acute myocardial infarction hasdecreased dramatically in modern times due to the progress of reperfusion therapy, LVT incidence in patients with anterior STEMI remains at 4% to 26%.10,12 It complicates acute myocardial infarction and is associated with a higher incidence of poor outcomes.9


Eligibility criteria: Inclusion Criteria:

* patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel

Exclusion Criteria:

1. Patients with liver cirrhosis.
2. Patients with severe mitral stenosis .
3. Patients with bleeding tendency (HASBLED score ≥ 3)
4. Severe renal impairment ( creatinine clearance \< 30 ml/min ).
5. patients with prosthetic valve .
6. patients on ticagrelor treatment
7. patients with Atrial Fibrillation

Primary outcomes:
measure: Major adverse cardiovascular event
timeFrame: 10 months
measure: Left ventricular function
timeFrame: 10 months
measure: Left ventricular thrombus
timeFrame: 10 months
measure: Transient Ischemic Attacks or cerebrovascular stroke
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Bhatt DL, Eagle KA, Ohman EM, Hirsch AT, Goto S, Mahoney EM, Wilson PW, Alberts MJ, D'Agostino R, Liau CS, Mas JL, Rother J, Smith SC Jr, Salette G, Contant CF, Massaro JM, Steg PG; REACH Registry Investigators. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010 Sep 22;304(12):1350-7. doi: 10.1001/jama.2010.1322. Epub 2010 Aug 30.
citation: Merlini PA, Bauer KA, Oltrona L, Ardissino D, Cattaneo M, Belli C, Mannucci PM, Rosenberg RD. Persistent activation of coagulation mechanism in unstable angina and myocardial infarction. Circulation. 1994 Jul;90(1):61-8. doi: 10.1161/01.cir.90.1.61.
citation: Ueda Y, Ogasawara N, Matsuo K, Hirotani S, Kashiwase K, Hirata A, Nishio M, Nemoto T, Wada M, Masumura Y, Kashiyama T, Konishi S, Nakanishi H, Kobayashi Y, Akazawa Y, Kodama K. Acute coronary syndrome: insight from angioscopy. Circ J. 2010 Mar;74(3):411-7. doi: 10.1253/circj.cj-09-0795. Epub 2010 Jan 30.
citation: Borissoff JI, Spronk HM, Heeneman S, ten Cate H. Is thrombin a key player in the 'coagulation-atherogenesis' maze? Cardiovasc Res. 2009 Jun 1;82(3):392-403. doi: 10.1093/cvr/cvp066. Epub 2009 Feb 19.