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NCT Number: NCT05193019

Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

This registry will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI (Percutaneous Coronary Intervention) setting and will investigate as well the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of "real-world" patients undergoing PCI in Spain.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

The present study is an observational, multicenter, nationwide, prospective investigation in patients undergoing PCI due to any coronary syndrome (acute or chronic) and receiving parenteral antiplatelet agents, GPIs or cangrelor, as per clinical practice during the procedure.

This investigation will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI setting and will evaluate the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of patients undergoing PCI in Spain.

Approximately 15 high-volume PCI-capable Spanish centers will participate in the present investigation with the intention to enroll circa 1.000 patients.

The study is purely observational and no intervention will be performed in the included subjects because due to their participation in this investigation.

Patients fulfilling inclusion and exclusion criteria will be included after providing written informed consent to participate in the current investigation. Patient characteristics, procedural details and pharmacological therapies will be collected after inclusion and clinical events will be registered at two time points: 48 hours and 30 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parenteral antiplatelet agents

Other

Patients undergoing PCI and receiving parenteral antiplatelet agents, cangrelor or glycoprotein IIb/IIIa inhibitors (GPIs), during the procedure as per clinical practice

Primary outcomes

  1. Rate of Net Adverse Clinical Events (NACE)

    Time frame: 48 hours

    NACE defined as a the composite of all-cause death, recurrent myocardial infarction, stroke, target vessel revascularization, definite or probable stent thrombosis and BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure

Secondary outcomes

  1. Death

    Time frame: 48 hours

    All-cause of death will be evaluated at 48 hours from index procedure

  2. Myocardial infarction

    Time frame: 48 hours

    Recurrent myocardial infarction will be evaluated at 48 hours from index procedure

  3. Stroke

    Time frame: 48 hours

    Stroke will be evaluated at 48 hours from index procedure

  4. Target Vessel Revascularization

    Time frame: 48 hours

    Target Vessel will be evaluated at 48 hours from index procedure

  5. Definite or probable stent thrombosis

    Time frame: 48 hours

    Definite or probable stent thrombosis will be evaluated at 48 hours from index procedure

  6. BARC bleeding

    Time frame: 48 hours

    BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure

  7. Rate of Net Adverse Clinical Events (NACE)

    Time frame: 30 days

    NACE defined as a the composite of all-cause death, recurrent myocardial infarction, stroke, target vessel revascularization, definite or probable stent thrombosis and BARC bleeding (type 2,3 and 5) will be evaluated at 30 days from index procedure

  8. Death

    Time frame: 30 days

    All-cause of death will be evaluated at 30 days from index procedure

  9. Myocardial infarction

    Time frame: 30 days

    Recurrent myocardial infarction will be evaluated at 30 days from index procedure

  10. Stroke

    Time frame: 30 days

    Stroke will be evaluated at 30 days from index procedure

  11. Target Vessel Revascularization

    Time frame: 30 days

    Target Vessel Revascularization will be evaluated at 30 days from index procedure

  12. Definite or probable stent thrombosis

    Time frame: 30 days

    Definite or probable stent thrombosis will be evaluated at 30 days from index procedure

  13. BARC bleeding

    Time frame: 30 days

    BARC bleeding will be evaluated at 30 days from index procedure

  14. Cardiac death

    Time frame: 48 hours

    Cardiac death will be evaluated at 48 hours from index procedure

  15. Cardiac death

    Time frame: 30 days

    Cardiac death will be evaluated at 30 days from index procedure

  16. Transition to oral P2Y12 inhibitors

    Time frame: 24 hours

    Proportion of patients transitioned to each oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) after the use of each parenteral antiplatelet agent (GPIs or cangrelor) will be evaluated at 24 hours from index procedure

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

Practice Patterns of Antithrombotic Therapy in REAL-world Patients Undergoing PCI in Spain: Parenteral Antiplatelet Agents

Acronym: PATREAL

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2022
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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