Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event

Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event - Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event (PENDULUM registry)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000020332

Enrollment

5000

Registered

2015-12-25

Start date

2015-12-31

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

Patients with ACS or elective indications undergoing PCI with drug-eluting stent implantation.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients are included in the study if all of the following criteria are met: 1.Patients 20 years of age or older at the time of informed consent 2.Patients who have coronary lesions visually confirmed by coronary angiography and are indicated for PCI with drug eluting stent (patients would be judged by referring package insert.). 3.Patients who are treated with antiplatelet drug(s) after hospitalization to discharge to undergo PCI with drug eluting stent. 4.Patients who agreed to participate in the clinical study after being informed in detail

Exclusion criteria

Exclusion criteria: Patients are excluded from the study if the following criteria is met: Patients who are in or plan to participate in such clinical study/ research before the end of follow-up in this study.

Design outcomes

Primary

Measure	Time frame
Efficacy: The incidence of the composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and stent thrombosis at 12 months after index PCI. Safety: The incidence of major bleeding at 12 months after index PCI. (Major bleeding: BARC type 3 or type 5)	—

Secondary

Measure	Time frame
The incidence of the events listed below within 1 month and 30 months after index PCI. The incidence of composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis The incidence of major bleeding. The incidence of the events listed below within 1 month, 12 months and 30 months after index PCI. Bleeding event (each category according to BARC criteria; major bleeding and minor bleeding according to TIMI criteria). Major adverse clinical, cardiac or cerebral events (all-cause death, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, nonfatal ischemic stroke, revascularization (TVR, TLR), TIA, stent thrombosis, and peripheral arterial occlusive disease)	—

Measure

Time frame

The incidence of the events listed below within 1 month and 30 months after index PCI. The incidence of composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis The incidence of major bleeding. The incidence of the events listed below within 1 month, 12 months and 30 months after index PCI. Bleeding event (each category according to BARC criteria; major bleeding and minor bleeding according to TIMI criteria). Major adverse clinical, cardiac or cerebral events (all-cause death, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, nonfatal ischemic stroke, revascularization (TVR, TLR), TIA, stent thrombosis, and peripheral arterial occlusive disease)

—

Countries

Japan

Contacts

Public ContactMasashi Odani

CMIC Co., Ltd. Academia Clinical Research Div.

masashi-odani@cmic.co.jp03-6779-8172

Outcome results