CHAOS Registry Study

Atrial Fibrillation Clinical Trial

— CHAOS  

Official title:

CHoosing Triple or Double therApy in the Era of nOac for patientS Undergoing PCI: the CHAOS a Multicenter Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03558295
• Other study ID #: CHAOS
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2018
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Fabrizio D'Ascenzo, MD
• Phone: +390116335570
• Email: fabrizio.dascenzo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with final diagnosis of CAD (stable CAD or ACS) treated with oral anticoagulants and who undwerwent a coronary artery intervention

• Age = 18 years

• Obtained informed consent

Exclusion Criteria:

• Oral anticoagulation indication other than atrial fibrillation

• Patients who underwent revascularization with thrombolysis or with BPAC

• Patients in active treatment with anti-cancer therapy

• Patients with a non obstructive coronary artery disease

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases
• Ischem Heart Disease
• Oral Anticoagulants
• Primary Coronay Intervention

Intervention

Drug:
• Oral Anticoagulant
warfarin, dabigatran, rivaroxaban, edoxaban

Locations

Country	Name	City	State
Italy	Città della Salute e della Scienza di Torino	Torino	Piemonte

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

References & Publications (11)

Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithr — View Citation

Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. — View Citation

Dans AL, Connolly SJ, Wallentin L, Yang S, Nakamya J, Brueckmann M, Ezekowitz M, Oldgren J, Eikelboom JW, Reilly PA, Yusuf S. Concomitant use of antiplatelet therapy with dabigatran or warfarin in the Randomized Evaluation of Long-Term Anticoagulation The — View Citation

Dewilde WJ, Oirbans T, Verheugt FW, Kelder JC, De Smet BJ, Herrman JP, Adriaenssens T, Vrolix M, Heestermans AA, Vis MM, Tijsen JG, van 't Hof AW, ten Berg JM; WOEST study investigators. Use of clopidogrel with or without aspirin in patients taking oral a — View Citation

Gibson CM, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Birmingham M, Ianus J, Burton P, van Eickels M, Korjian S, Daaboul Y, Lip GY, Cohen M, Husted S, Peterson ED, Fox KA. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing — View Citation

Hansen ML, Sørensen R, Clausen MT, Fog-Petersen ML, Raunsø J, Gadsbøll N, Gislason GH, Folke F, Andersen SS, Schramm TK, Abildstrøm SZ, Poulsen HE, Køber L, Torp-Pedersen C. Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and — View Citation

Oldgren J, Budaj A, Granger CB, Khder Y, Roberts J, Siegbahn A, Tijssen JG, Van de Werf F, Wallentin L; RE-DEEM Investigators. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase — View Citation

Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. — View Citation

Sarafoff N, Martischnig A, Wealer J, Mayer K, Mehilli J, Sibbing D, Kastrati A. Triple therapy with aspirin, prasugrel, and vitamin K antagonists in patients with drug-eluting stent implantation and an indication for oral anticoagulation. J Am Coll Cardio — View Citation

Sørensen R, Hansen ML, Abildstrom SZ, Hvelplund A, Andersson C, Jørgensen C, Madsen JK, Hansen PR, Køber L, Torp-Pedersen C, Gislason GH. Risk of bleeding in patients with acute myocardial infarction treated with different combinations of aspirin, clopido — View Citation

Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Jüni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group. 2017 ESC focused update on — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary (efficacy and safety) end-points:Net Adverse Clinical Event - NACE	Primary (efficacy and safety) end-points: - Net Adverse Clinical Event - NACE at 12 months of follow up (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 (8,9): all events mutually exclusive); expressed as a rate of events.	12 months
Primary	Primary (efficacy and safety) end-points:Major Adverse Cardiac Event - MACE at 12 months	Primary (efficacy and safety) end-points: - Major Adverse Cardiac Event - MACE at 12 months of follow up (a composite end points including death, myocardial infarction (excluding periprocedural myocardial infarction), stent thrombosis, revascularization, stroke); expressed as a rate of events.	12 months
Secondary	Cardiac death	Expressed as a rate of events.	after 12 months
Secondary	Target vessel revascularization (TVR) and non TVR and the number of the revascularization.	Expressed as a rate of events.	after 12 months
Secondary	Death	Expressed as a rate of events.	after 12 months
Secondary	Myocardial infarction	Expressed as a rate of events.	after 12 months
Secondary	Stent thrombosis	Expressed as a rate of events.	after 12 months
Secondary	Recurrent revascularization	Expressed as a rate of events.	after 12 months
Secondary	Stroke	Expressed as a rate of events.	after 12 months
Secondary	Bleeding BARC [Bleedings according to the Bleeding Academic Research Consortium] 2,3,5 (8,9): all events mutually exclusive); expressed as a rate of events.	According with BARC [Bleedings according to the Bleeding Academic Research Consortium] 2,3,5 (8,9): all events mutually exclusive); expressed as a rate of events.	after 12 months