NCT05573958: ACCP

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

Status unknown Phase 4 Last updated 10 October 2022

What this trial tests

Phase 4 trial testing Rivaroxaban 2.5 Mg Oral Tablet in Acute Coronary Syndrome in 90 participants. Status unknown.

Timeline

1 October 2022

Primary endpoint
31 March 2023

31 July 2023

Quick facts

Lead sponsor	Sarmad Zahoor
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	1 October 2022
Primary completion	31 March 2023
Estimated completion	31 July 2023

Drugs / interventions tested

• Rivaroxaban 2.5 Mg Oral Tablet
• Clopidogrel tablet — full drug profile →
• Aspirin tablet

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →

Sponsor

Sarmad Zahoor

Who can join

18 and older, any sex, with Acute Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.