Observational study on antiplatelet agents in Spanish PCI patients
Practice Patterns of Antithrombotic Therapy in REAL-world Patients Undergoing PCI in Spain: Parenteral Antiplatelet Agents
This study is looking to see how well certain antiplatelet medications work and how safe they are for people in Spain who are getting heart procedures called PCI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 12 sites (Hospitalet de Llobregat, Barcelona and 11 other locations) |
| Trial ID | NCT05193019 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather descriptive data on the use of parenteral antiplatelet therapy during Percutaneous Coronary Intervention (PCI) in Spain. It will evaluate the short-term effectiveness and safety of agents like glycoprotein IIb/IIIa inhibitors and cangrelor in real-world patients undergoing PCI for ischemic heart disease or acute coronary syndrome. Approximately 1,000 patients will be enrolled from around 15 high-volume centers, with data collected on patient characteristics and clinical events at two time points: 48 hours and 30 days post-procedure.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing PCI and will receive parenteral antiplatelet agents during the procedure.
Not a fit: Patients with blood disorders, active bleeding, or those on chronic anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the effectiveness and safety of parenteral antiplatelet agents, potentially improving patient outcomes in PCI procedures.
How similar studies have performed: While this study is observational, similar studies have shown success in evaluating antiplatelet therapies in PCI settings, suggesting a foundation for potential insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Undergoing a PCI * Use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI) Exclusion Criteria: * Blood dyscrasia, bleeding diathesis or active bleeding at the time of the index procedure. * Chronic oral anticoagulation. * Recent history of stroke, TIA (Transient Ischemic Attack)or intracranial bleeding (\<3 months prior to inclusion). * Severe anemia (Hb\<9g/dl) or platelet count \<100x106/ml at the time of the index procedure. * Any active neoplasm.
Where this trial is running
Hospitalet de Llobregat, Barcelona and 11 other locations
- Hospital Universitari de Bellvitge — Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Universitario de Cruces — Barakaldo, Spain (Recruiting)
- Hospital de Galdakao — Galdakao, Spain (Recruiting)
- Hospital Universitario de Cabueñes — Gijón, Spain (Recruiting)
- H.de Leon — León, Spain (Recruiting)
- Hospital Central de La Defensa Gómez Ulla — Madrid, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Spain (Recruiting)
- Hospital Clinico Universitario de Salamanca — Salamanca, Spain (Recruiting)
- Hospital Universitario Marques de Valdecilla — Santander, Spain (Recruiting)
- Hospital Clinico Universitario Santiago de Compostela — Santiago De Compostela, Spain (Recruiting)
- Hospital Universitari Joan Xxiii — Tarragona, Spain (Recruiting)
- Hospital Universitario Lozano Blesa — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: José Luis Ferreiro Gutiérrez, MD, PhD
- Email: jlferreiro@bellvitgehospital.cat
- Phone: +34 93 2607539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.