Status:
RECRUITING
Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol
Lead Sponsor:
West China Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Brief Summary
Percutaneous coronary intervention (PCI) is an important treatment strategy for patients with coronary artery disease. Combined bleeding after PCI significantly increases the risk of death in patients...
Detailed Description
This trail is a single center investigator-initiated prospective registry. PPP-PCI aims to observe the characteristics and prognosis of the PCI-HBR population and to explore appropriate antiplatelet t...
Eligibility Criteria
Inclusion
- PCI patients \>18 years of age and meeting 1 major criterion or 2 minor criteria of the ARC-HBR The ARC-HBR major criteria included:
- long-term use of oral anticoagulants;
- severe or end-stage chronic kidney disease \[eGFR \<30 ml/(min\*1.73m2 )\];
- hemoglobin \<11 g/dl, spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time;
- chronic bleeding constitutional;
- cirrhosis with portal hypertension spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time;
- moderate to severe baseline thrombocytopenia (platelets \<100×10\^9/L); chronic bleeding constitutional;
- cirrhosis with portal hypertension;
- active malignancy within the past 12 months (excluding non-melanoma skin cancer);
- previous spontaneous brain hemorrhage (at any time);
- traumatic brain hemorrhage within the past 12 months;
- within the past 6 months moderate or severe ischemic stroke within the past 6 months;
- the presence of cerebral arteriovenous malformation;
- recent major surgery or major trauma within 30 days prior to PCI;
- and major non-delayable surgery during DAPT.
- Secondary criteria included:
- age ≥75 years;
- moderate chronic kidney disease \[30 ml/(min\*1.73m2 ) ≤ eGFR ≤ 59 ml/(min\*1.73m2 )\];
- 11 g/dl ≤ hemoglobin \< 13 g/dl in men and 11 g/dl ≤ hemoglobin \< 12 g/dl in women; - spontaneous bleeding requiring hospitalization or blood transfusion in the past 6 months to 12 months;
- long-term use of oral NSAIDs or steroids
- Ischemic stroke of any duration not covered by the primary criteria.
Exclusion
- Patients who were already bleeding at the time of baseline inclusion
- Patients who could not be followed up (including previously reserved phone changes, etc.) to obtain MACE events.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT05369442
Start Date
May 1 2022
End Date
August 1 2029
Last Update
January 6 2026
Active Locations (1)
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1
West China Hospital, Sichuan University
Sichuan, Sichuan, China, 610041