NCT03558295: CHAOS

CHAOS Registry Study

Status unknown Last updated 15 June 2018

What this trial tests

trial testing Oral Anticoagulant in Ischem Heart Disease in 1,000 participants. Status unknown.

Timeline

1 May 2018

Primary endpoint
31 October 2018

31 December 2018

Quick facts

Lead sponsor	A.O.U. Città della Salute e della Scienza
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 May 2018
Primary completion	31 October 2018
Estimated completion	31 December 2018
Sites	1 location across Italy

Drugs / interventions tested

• Oral Anticoagulant (oral-anticoagulant) — full drug profile →

Conditions studied

• Ischem Heart Disease — all drugs for Ischem Heart Disease →
• Primary Coronay Intervention — all drugs for Primary Coronay Intervention →
• Oral Anticoagulants — all drugs for Oral Anticoagulants →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

A.O.U. Città della Salute e della Scienza — full company profile →

Who can join

Adults 18 to 100, any sex, with Ischem Heart Disease or Primary Coronay Intervention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

INTRODUCTION: About 6-8% of patients undergoing PCI have an indication for long-term oral anticoagulants (OACs) due to various conditions such as atrial fibrillation (AF), mechanical heart valves, or venous thromboembolism. The addition of single or double antiplatelet therapy to OACs therapy results in an increase in bleeding complications (1-4). The standard of care of management in this patients, indicated by 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease (5), recommends the use of a triple therapy (Aspirin, clopidogrel and OAC) for 1-6 months (depending on the ischemic and hemorrhagic risk), then continue with double therapy only up to twelve month (Aspirin or clopidogrel and OAC) and after twelve months continue with the OAC only; the use of prasugrel or ticagrelor as part of triple therapy should be avoided (6). Only RELY study enrolled a small number of patients, less than one thousand, treated with dabigatran plus DAPT. Moreover, In the recent RCTs (WOEST(7), PIONEER AF-PCI study(8) and REDUAL-PCI(9)) only the double therapy (Aspirin or Clopidogrel/ticagrelor and DOAC) against triple therapy with warfarin was tested; and furthermore patients enrolled in RCTs represent only a small and not always representative sample of people treated in everyday clinical practice, who report a large burden of comorbidities and an older age. Randomized head to head comparison of warfarin and DOACs life-long (over 12 months from the PCI) have not been performed yet with clinical events as end points.

AIMS: Aim of the present study is to describe the contemporary management of patients who underwent a PCI and have an indication to OAC for AF evaluating the different types of combination therapies used (triple therapy with warfarin or with DOAC, single anti-platelet therapy plus warfarin or DOAC) and their management in the first year after a PCI in a "real-life" setting. Secondary we would also evaluate the safety (in term of bleedings) and the efficacy (in term of ischemic and cardioembolic events) of the use of the different combination of single or double antiplatelet with OACs, in patients with coronary artery disease.

MATERIALS AND METHODS: This is a retrospective, multicenter study including patients presenting with coronary artery disease (acute or stable setting) undergoing to PCI, in single or double antiplatelet therapy (aspirin, clopidogrel, ticagrelor, prasugrel, aspirin and clopidogrel, aspirin and ticagrelor, aspirin and prasugrel) with an indication to anticoagulant therapy (warfarin, dabigatran, rivaroxaban, edoxaban). The different groups will be compared with a propensity score analysis with matching.

Primary (efficacy) end-points:

* A composite end points including death, myocardial infarction, stent thrombosis, revascularization stroke (MACE).
* A composite end points including death, myocardial infarction, stent thrombosis, revascularization, stroke and BARC \[Bleedings according to the Bleeding Academic Research Consortium\] 2,3,5 (7,8): all events mutually exclusive (NACE).

Secondary end-points: Individual components of NACE; Cardiac death; Stroke; Target vessel revascularization (TVR) and non TVR and the number of the revascularization.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.