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

NCT ID: NCT05573958

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-07-31

Brief 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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Rivaroxaban, Clopidogrel, and Aspirin

Rivaroxaban 2.5 mg tablet twice daily orally, Clopidogrel 75 mg tablet once daily orally, and Aspirin 81 mg tablet once daily

Group Type: EXPERIMENTAL

Rivaroxaban 2.5 Mg Oral Tablet

Intervention Type: DRUG

Rivaroxaban 2.5 mg oral tablet will be administered twice daily

Clopidogrel tablet

Intervention Type: DRUG

Clopidogrel 75 mg once daily orally

Aspirin tablet

Intervention Type: DRUG

Aspirin 81 mg tablet once daily

Arm B: Clopidogrel and Aspirin

Clopidogrel 75 mg tablet once daily, and Aspirin 81 mg tablet once daily

Group Type: ACTIVE_COMPARATOR

Clopidogrel tablet

Intervention Type: DRUG

Clopidogrel 75 mg once daily orally

Aspirin tablet

Intervention Type: DRUG

Aspirin 81 mg tablet once daily

Interventions

Rivaroxaban 2.5 Mg Oral Tablet

Rivaroxaban 2.5 mg oral tablet will be administered twice daily

Intervention Type: DRUG

Clopidogrel tablet

Clopidogrel 75 mg once daily orally

Intervention Type: DRUG

Aspirin tablet

Aspirin 81 mg tablet once daily

Intervention Type: DRUG

Other Intervention Names

Xarelto; Plavix; Acetylsalicylic acid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Managemant and Technology, Pakistan

UNKNOWN

Sponsor Role: collaborator

Mayo Hospital Lahore

OTHER

Sponsor Role: collaborator

Sarmad Zahoor

OTHER

Sponsor Role: lead

Responsible Party

Sarmad Zahoor

Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Dr. Sarmad Zahoor, MBBS

Role: CONTACT

drsarmadzahoor@gmail.com

03336431557

Dr. Muhammad Sajid Jehangir, MBBS, FCPS

Role: CONTACT

sajidroomi@gmail.com

03456610346

Other Identifiers

PIC-2022-06

Identifier Type: -

Identifier Source: org_study_id