Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Completed

Conditions studied: Cardiac Disease

In brief

Aim(s)/Objective(s) * To evaluate the safety and efficacy of triple antithrombotic therapy in patients taking DAPT of aspirin and a P2Y12 inhibitor in addition to either a NOAC or warfarin for the prevention of thromboembolic or acute coronary syndrome (ACS) events in patients with non-valvular atrial fibrillation (AF), history of coronary artery disease (CAD)/stent placement or recurrent ACS event. * To determine the Methodist Health System (MHS) prescribing practices and patterns in cardiac patients with a history of AF who are admitted for CAD or an ACS event requiring PCI. Hypothesis Primary Hypothesis Cardiac patients with a history of AF and an indication for long-term NOAC who are also prescribed DAPT following an ASC event or revascularization with stenting will demonstrate a significant difference in cardiovascular outcomes and major bleeding events when compared with warfarin-based triple therapy.

Key facts

Study ID

NCT03889574

Run by

Methodist Health System

People needed

84

Starts

2019-02-26

Expected to finish

2019-06-27

Last updated by the study team

2020-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 18 years or older
• AF diagnosis
• ICD10 for ACS, STEMI or NSTEMI
• Discharged with triple therapy agents of aspirin, P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), and OAC (warfarin, edoxaban, dabigatran, rivaroxaban, or apixaban) status post-stent

You may not qualify if…

• • Patients less than 18 years of age
• Prior intracranial bleeding prior to study start date
• GI hemorrhage within 1 month prior to study start date
• Major bleeding event with 1 month prior to study start date
• Hemorrhage disorder
• Stroke within 1 month prior to study start date
• Cardiogenic shock during admission at start date
• Contraindication to use of the study medications
• Peptic ulcer in the prior 6 months prior to study start date
• Thrombocytopenia (platelet concentration lower than 50×109/L)
• Thrombolysis In Myocardial Infarction (TIMI) major bleeding in the prior 12 months of study start date
• Pregnancy
• History of DVT or PE currently on OAC

Where it is running

• Methodist Dallas Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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