NCT04291287

Brief Summary

Aim of this study is to describe clinical and procedural characteristics of real-world population initiated on triple antithrombotic therapy (double antiplatelet therapy+anticoagulant) or double antithrombotic therapy (single antiplatelet therapy+anticoagulant) after percutaneous coronary intervention (PCI). Investigator's driven trial, retrospective (2015-2019), multicenter Italian registry. Baseline clinical characteristics as well as procedural details will be collected retrospectively. Follow-up data (minimum 6 months and maximum 5 years follow-up) will focus on combined rates of stent thrombosis and myocardial infarction (primary endpoint).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

February 28, 2020

Last Update Submit

March 25, 2020

Conditions

Atrial FibrillationMyocardial InfarctionAnticoagulant-induced BleedingCoronary Disease

Keywords

DOACsNOACsAntiplatelet therapyClopidogrelAspirinPCIStent thrombosisMajor bleedingIctusTIA

Outcome Measures

Primary Outcomes (1)

  • Stent thrombosis and acute myocardial infarction

    composite endpoint of the occurrence of stent thrombosis and acute myocardial infarction (MI) at 1 year

    up to 1-year since the initiation of antithrombotic therapy

Secondary Outcomes (2)

  • Major bleeding

    up to 1-year since the initiation of antithrombotic therapy

  • Thromboembolic events

    up to 1-year since the initiation of antithrombotic therapy

Study Arms (2)

Triple antithrombotic therapy

patients taking Triple antithrombotic therapy (aspirin and a P2Y12 inhibitor, in addition to either a DOACs or warfarin/acenocumarol)

Drug: Antithrombotic Agent

Dual antithrombotic therapy

patients taking Dual antithrombotic therapy (aspirin or P2Y12 inhibitor in addition to either a DOACs or warfarin/acenocumarol)

Drug: Antithrombotic Agent

Interventions

Antithrombotic AgentDRUG

Adenosine diphosphate (ADP) receptor antagonists (or P2Y12 inhibitors) therapy include: * Clopidogrel (Plavix®) * Prasugrel (Efient®) * Ticagrelor (Brilique®) DOACs therapy include: * Apixaban (Eliquis®) * Dabigatran (Pradaxa®) * Edoxaban (Lixiana®) * Rivaroxaban (Xarelto®). Oral anticoagulant therapy (OAT) include: * Warfarin (Counmadin®) * Acenocumarol (Sintrom®)

Dual antithrombotic therapyTriple antithrombotic therapy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients with a diagnosis of non valvular atrial fibrillation (or atrial flutter treated) with PCI and stent (drug eluting or bare metal stent) requiring triple antithrombotic therapy (double antiplatelets agents and oral anticoagulation) or dual antithrombotic therapy (single antiplatelet agent and oral anticoagulation) * Patients with NVAF treated for elective PCI (in the contest of chronic coronary syndromes) or urgent (in the contest of an acute coronary syndromes: STEMI, NSTEMI, unstable angina).

You may qualify if:

  • Patients aged 18 years or older
  • Patients with a diagnosis of non valvular atrial fibrillation (or atrial flutter treated) with PCI and stent (drug eluting or bare metal stent) requiring triple antithrombotic therapy (double antiplatelets agents and oral anticoagulation) or dual antithrombotic therapy (single antiplatelet agent and oral anticoagulation)
  • Patients with NVAF treated for elective PCI (in the contest of chronic coronary syndromes) or urgent (in the contest of an acute coronary syndromes: STEMI, NSTEMI, unstable angina).
  • Patients who give the informed consent.

You may not qualify if:

  • Patients with less than 6 months of clinical follow-up availability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cosmo Godino

Milan, 20131, Italy

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationMyocardial InfarctionCoronary Disease

Interventions

Fibrinolytic Agents

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaVascular DiseasesInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

Fibrin Modulating AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCardiovascular AgentsTherapeutic UsesHematologic Agents

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 2, 2020

Study Start

January 25, 2020

Primary Completion

February 28, 2022

Study Completion

September 30, 2022

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)