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

NCT05573958 | Unknown Phase 4 DMC

• 1 other identifier: PIC-2022-06
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  Myocardial infarction, Arrhythmia, Stroke, Pulmonary Edema, Death

  3 months

Study Arms (2)

Arm A: Rivaroxaban, Clopidogrel, and Aspirin

EXPERIMENTAL

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

Drug: Rivaroxaban 2.5 Mg Oral Tablet; Drug: Clopidogrel tablet; Drug: Aspirin tablet

Arm B: Clopidogrel and Aspirin

ACTIVE COMPARATOR

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

Drug: Clopidogrel tablet; Drug: Aspirin tablet

Interventions

Rivaroxaban 2.5 Mg Oral Tablet DRUG

Rivaroxaban 2.5 mg oral tablet will be administered twice daily

Also known as: Xarelto

Arm A: Rivaroxaban, Clopidogrel, and Aspirin

Clopidogrel tablet DRUG

Clopidogrel 75 mg once daily orally

Also known as: Plavix

Arm A: Rivaroxaban, Clopidogrel, and Aspirin; Arm B: Clopidogrel and Aspirin

Aspirin tablet DRUG

Aspirin 81 mg tablet once daily

Also known as: Acetylsalicylic acid

Arm A: Rivaroxaban, Clopidogrel, and Aspirin; Arm B: Clopidogrel and Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarmad Zahoor: lead
• University of Managemant and Technology, Pakistan: collaborator
• Mayo Hospital Lahore: collaborator

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rivaroxaban; Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Dr. Sarmad Zahoor, MBBS

CONTACT

03336431557; drsarmadzahoor@gmail.com

Dr. Muhammad Sajid Jehangir, MBBS, FCPS

CONTACT

03456610346; sajidroomi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: October 10, 2022
• Study Start: October 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share