To Assess the Efficacy and Safety of Dual Anticoagulants i.e. Rivaroxaban Plus Aspirin and Clopidogrel Plus Aspirin in Patients Suffering From an Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— ACCP  

Official title:

Open-label Randomized Control Trial to Assess the Efficacy and Safety of Dual Anticoagulants i.e. Rivaroxaban Plus Aspirin and Clopidogrel Plus Aspirin in Patients Suffering From an Acute Coronary Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05573958
• Other study ID #: PIC-2022-06
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2022
• Source: Punjab Institute of Cardology
• Contact: Dr. Sarmad Zahoor, MBBS
• Phone: 03336431557
• Email: drsarmadzahoor[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Direct-acting oral anticoagulants (DOACs) have provided benefits to patients requiring anticoagulation for certain diseases by decreasing the burden of subcutaneous injections and the requirement for frequent monitoring through regular blood tests. DOACs do not require monitoring, have a more predictable pharmacokinetic (dosing) profile and have fewer interactions with other drugs. Various studies have reported the efficacy and safety of different dual-acting anticoagulants around the globe. However, there is little data available from Pakistan. Therefore, investigators propose this study to assess the efficiency and safety of rivaroxaban and clopidogrel along with aspirin in patients suffering from acute coronary syndrome. The objective of this study is to investigate the efficacy of dual anticoagulants i.e. aspirin plus rivaroxaban versus aspirin plus clopidogrel in patients suffering from acute coronary syndrome in terms of secondary prophylaxis. All the patient records will be documented in Case Report Form (CRF) at each visit. All data will be recorded in individual source documents. All CRF information is to be filled in by site staff. If an item is not available or is not applicable, this fact should be indicated. Blank spaces should not be present unless otherwise directed. The study monitor will perform source data verification of data entered into the CRF. The data entered into the CRF will be subject to data validation checks for consistency and completeness by the data management group. All CRFs should be maintained on the system with details of any changes logged accordingly.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female aged = 18 years and above

• Participants able to understand the study procedures and willing to give written informed consent/assent to participate in the trial

• Participants willing to follow the study procedures of the study and available for the entire duration of the study.

• Female participants of childbearing potential must have a negative urine pregnancy test

• Women of childbearing potential (WOCBP) must be willing to abstain from heterosexual activities or agree to use highly effective, double-barrier contraception during the study and for 90 days following the final dose of study treatment, to avoid pregnancy. (This is in line with regulatory Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals)

Exclusion Criteria:

• Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes

• Arrhythmias

• Pre-existing hepatic disease

• Pre-existing renal disease

• Already taking any drug

• Pregnancy

• Thyroid dysfunctions

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Rivaroxaban 2.5 Mg Oral Tablet
Rivaroxaban 2.5 mg oral tablet will be administered twice daily
• Clopidogrel tablet
Clopidogrel 75 mg once daily orally
• Aspirin tablet
Aspirin 81 mg tablet once daily

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sarmad Zahoor	Mayo Hospital Lahore, University of Managemant and Technology, Pakistan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events (MACE)	Myocardial infarction, Arrhythmia, Stroke, Pulmonary Edema, Death	3 months