Patient With Anterior Myocardial InfarctionNCT05744804
Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction
A study testing -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg and (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only) in people with Patient With Anterior Myocardial Infarction, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Patient With Anterior Myocardial Infarction
- What is being tested?
- -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg and (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel
Who cannot join
- Patients with liver cirrhosis.
- Patients with severe mitral stenosis .
- Patients with bleeding tendency (HASBLED score ≥ 3)
- Severe renal impairment ( creatinine clearance < 30 ml/min ).
- patients with prosthetic valve .
- patients on ticagrelor treatment
- patients with Atrial Fibrillation
Trial locations and contacts
1 site in 1 country.
Sharaf Eldin S Abdallah, professor contact
About this study
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
- Being tested
- -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg, (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
-group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mgDrug
receive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally)
(acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)Drug
control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only
| Study group | Role | What they receive |
|---|---|---|
| -group of patients(75 patients) will receive low dose rivaroxaban | Active comparator | -group of patients(75 patients) will receive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and cloppe Receives: Drug: -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg |
| control group of patients: | Active comparator | control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only Receives: Drug: (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular event
Major adverse cardiovascular event
Measured: 10 months
Left ventricular function
Left ventricular function
Measured: 10 months
Left ventricular thrombus
Left ventricular thrombus
Measured: 10 months
Transient Ischemic Attacks or cerebrovascular stroke
Transient Ischemic Attacks or cerebrovascular stroke
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patient With Anterior Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elamir Saber, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744804
- Sponsor's protocol ID
- soh-Med-23-01-09
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20805624Merlini 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.
PubMed 8026047Ueda 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.
PubMed 20118566Borissoff 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.
PubMed 19228706
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05744804
- Acronym / sponsor ID
- soh-Med-23-01-09
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| -group of patients(75 patients) will receive low dose rivaroxaban | Active comparator | Drug: -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg-group of patients(75 patients) will receive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and cloppe |
| control group of patients: | Active comparator | Drug: (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel
Key exclusion criteria (7 listed)
- Patients with liver cirrhosis.
- Patients with severe mitral stenosis .
- Patients with bleeding tendency (HASBLED score ≥ 3)
- Severe renal impairment ( creatinine clearance < 30 ml/min ).
- patients with prosthetic valve .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mgreceive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally) | Drug | -group of patients(75 patients) will receive low dose rivaroxaban |
| (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only | Drug | control group of patients: |
Primary outcome
Major adverse cardiovascular event
Time frame: 10 months
Major adverse cardiovascular event
Left ventricular function
Time frame: 10 months
Left ventricular function
Left ventricular thrombus
Time frame: 10 months
Left ventricular thrombus
Transient Ischemic Attacks or cerebrovascular stroke
Time frame: 10 months
Transient Ischemic Attacks or cerebrovascular stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 20805624Bhatt 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.
- Background: PubMed 8026047Merlini 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.
- Background: PubMed 20118566Ueda 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.
- Background: PubMed 19228706Borissoff 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.
- Individual participant dataSharing planned: Undecided
Related trials for Patient With Anterior Myocardial Infarction
RecruitingPhase 2
Rituximab in Patients With ST-elevation Myocardial Infarction
ST Elevated Myocardial Infarction
Active, not recruiting
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
Left Ventricular Dysfunction, Coronary Artery Disease
RecruitingPhase 2
A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction
Acute Anterior ST-Segment Elevation Myocardial Infarction
Not yet recruitingPhase 2
Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
Acute Myocardial Infarction (AMI), Acute Myocardial Infarction of Anterior Wall
RecruitingPhase 3
Efficacy of Montelukast on STEMl Patients
Myocardial Infarction (MI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharaf Eldin S Abdallah, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg and (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only) in people with Patient With Anterior Myocardial Infarction, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Saber, resident (01150989566, mohamedelameer@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular event (time frame: 10 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744804, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.