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

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04047199
• Other study ID #: HAS-BLED-CHA2DS2-Vasc post-PCI
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: Mahmoud OS Morsy
• Phone: +201008406065
• Email: mahmood.osamaa[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 173
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients undergoing PCI

Exclusion Criteria:

• Those who had undergone unexpected immediate CABG

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Koene RJ, Win S, Naksuk N, Adatya SN, Rosenbaum AN, John R, Eckman PM. HAS-BLED and CHA2DS2-VASc scores as predictors of bleeding and thrombotic risk after continuous-flow ventricular assist device implantation. J Card Fail. 2014 Nov;20(11):800-7. doi: 10.1016/j.cardfail.2014.08.010. Epub 2014 Aug 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of bleeding events	number of bleeding events (epistaxis, bleeding gums, haematuria, GI bleeding, brain bleeding)	6 months after PCI
Primary	Rate of ischaemic events	number of ischaemic events (ACS, TIA, stroke, acute limb ischaemia, GI, ischaemia)	6 months after PCI