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Bleeding risk assessment of anticoagulation therapy in patients with both ischemic heart disease and atrial fibrillation after Percutaneous Coronary Intervention (comparison between direct oral anticoagulants and Warfarin)

Bleeding risk assessment of anticoagulation therapy in patients with both ischemic heart disease and atrial fibrillation after Percutaneous Coronary Intervention (comparison between direct oral anticoagulants and Warfarin) - Bleeding risk assessment of anticoagulation therapy in patients with both ischemic heart disease and atrial fibrillation after Percutaneous Coronary Intervention (comparison between direct oral anticoagulants and Warfarin)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000033844
Enrollment
Unknown
Registered
2018-08-21
Start date
2018-05-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic heart disease (IHD) and non-valvular atrial fibrillation (NVAF), undergone PCI with stent implantation

Interventions

None listed

Sponsors

DAIICHI SANKYO CO., LTD.
Lead Sponsor
CLINICAL STUDY SUPPORT, INC.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All of the following criteria are satisfied (Patients who have undergone PCI which satisfies all of the following criteria are included) -Underwent PCI between April 1, 2012 and May 31, 2017 -Diagnosed as both NVAF and IHD between 2 months before PCI and 1 month after PCI -Received dual antiplatelet therapy on the next day and 2 days after PCI -Prescribed DOAC or VKA from 1 to 7 days after PCI

Exclusion criteria

Exclusion criteria: Any of the following criteria is satisfied (Patients who have undergone PCI which satisfies the key inclusion criteria but all of whose PCIs satisfy any of the following criteria are excluded) -17 years of age or younger at the time of PCI -The follow-up started on or after June 1, 2017 -Prescribed both DOAC and VKA from 1 to 7 days after PCI -Not prescribed either thienopyridine antiplatelet agent or aspirin continuously at the start of follow-up. (All of the three components, i.e. anticoagulant, thienopyridine platelet agent, and aspirin, are not prescribed concomitantly.) The start of follow-up must be within the period of continuous prescription excluding grace period to judge that "the patient is continuously prescribed them at the start of follow-up." -The record of the date of PCI is the last record. We do not set the target sample size. All the patients who meet the key inclusion criteria and do not meet the key exclusion criteria are potential participants for this study.

Design outcomes

Primary

MeasureTime frame
Initial bleeding event observed during the follow-up period (any of the events from i to v below) i) Bleeding requiring blood transfusion ii) Intracranial bleeding iii) Intraocular bleeding iv) Upper gastrointestinal bleeding v) Lower gastrointestinal bleeding—

Secondary

MeasureTime frame
(1) Initial bleeding event observed during the follow-up period (each of the events from i to v described in the "primary outcomes" section) (2) All initial bleeding events observed during the follow-up period—

Countries

Japan

Contacts

Public ContactTakuyuki Matsumoto

DAIICHI SANKYO CO., LTD. Safety and Risk Management Department

matumoto.takuyuki.y2@daiichisankyo.co.jp03-6225-1192

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026