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Predictive Value of HAS-BLED and CHA2DS2-Vasc Scores After PCI

Predictive Value of HAS-BLED and CHA2DS2-Vasc Scores for Clinical Outcome After PCI

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04047199
Enrollment
173
Registered
2019-08-06
Start date
2019-12-01
Completion date
2020-07-01
Last updated
2019-08-26

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

Conditions

Percutaneous Coronary Intervention

Keywords

Percutaneous Coronary Intervention

Brief summary

To assess the predictive value of two scoring systems, namely HAS-BLED and CHA2DS2-VASc scores, to be linked with bleeding events and recurrence of chest pain and other measures of clinical outcome of percutaneous coronary intervention. The investigators aim to provide evidence for local guidelines of optimum options suited to our population

Detailed description

Dual-antiplatelet therapy (DAPT) with aspirin and an inhibitor of the platelet P2Y12 receptor is necessary to prevent stent-related thrombotic complications after percutaneous coronary intervention (PCI). (1) Although continuation of DAPT confers substantial and durable benefits that extend beyond the local stented segment, bleeding risk also increases with continued exposure to antiplatelet therapy. (2) Current guidelines give fixed duration of DAPT after coronary intervention but many patients still having early stent thrombosis despite this fixed policy, while others, on the contrary, suffer minor and major bleeding events. These clinical situations should raise the possibility of individualizing therapy. (5) The rationale of this study is to find a new method to tailor the optimal duration of DAPT for each patient by balancing long-term risks for both coronary thrombosis and major bleeding (MB). The HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score has long been used to predict bleeding events in patients on anticoagulation therapy. (3) Also, the CHA2DS2-VASc (congestive heart failure, hypertension, ≥75 years, diabetes, stroke/transient ischemic attack or thromboembolism, vascular disease, elderly, sex) score is a well-established system for prediction of thrombo-embolic events in patients with atrial fibrillation. (4) The aim of the present study is to evaluate the predictive ability of these 2 scoring tools when applied to patients undergoing PCI.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all patients undergoing PCI

Exclusion criteria

* Those who had undergone unexpected immediate CABG

Design outcomes

Primary

MeasureTime frameDescription
Rate of bleeding events6 months after PCInumber of bleeding events (epistaxis, bleeding gums, haematuria, GI bleeding, brain bleeding)
Rate of ischaemic events6 months after PCInumber of ischaemic events (ACS, TIA, stroke, acute limb ischaemia, GI, ischaemia)

Contacts

Primary ContactMahmoud OS Morsy
mahmood.osamaa@outlook.com+201008406065
Backup ContactHatem AH Aly
hatemabdelrahman@aun.edu.eg+201005212162

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026