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Ischemic Heart DiseasePATREALNCT05193019

Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

An observational study of Ischemic Heart Disease and Acute Coronary Syndrome, run by Fundación EPIC at 12 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Parenteral antiplatelet agents
How many people
717 participants
Where
12 sitesSpain
Study dates
14 Mar 2022to 1 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing a PCI and use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI)

Who may be able to join

  • Age ≥18 years
  • Undergoing a PCI
  • Use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI)

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Spain12 sites

  • Hospital Universitario de Cruces

    Barakaldo, 48903

  • Hospital de Galdakao

    Galdakao, 48960

  • Hospital Universitario de Cabueñes

    Gijón, 33394

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • H.de Leon

    León, 24080

  • Hospital Central de La Defensa Gómez Ulla

    Madrid, 28047

  • Hospital Universitario de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitari Joan Xxiii

    Tarragona, 43005

  • Hospital Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

About this study

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

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.

Read the detailed description

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.

Being tested
Parenteral antiplatelet agents
Keywords
Percutaneous Coronary Intervention, Antiplatelet Drugs, Cangrelor, Glycoprotein IIb/IIIa inhibitors
Medical subject headings
Myocardial Ischemia, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parenteral antiplatelet agentsOther

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

Study groups in NCT05193019
Study groupRoleWhat they receive
Patients undergoing PCINot described
Receives: Other: Parenteral antiplatelet agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Net Adverse Clinical Events (NACE)

    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

    Measured: 48 hours

Secondary outcomes (16)

  1. Death

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

    Measured: 48 hours

  2. Myocardial infarction

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

    Measured: 48 hours

  3. Stroke

    Stroke will be evaluated at 48 hours from index procedure

    Measured: 48 hours

  4. Target Vessel Revascularization

    Target Vessel will be evaluated at 48 hours from index procedure

    Measured: 48 hours

  5. Definite or probable stent thrombosis

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

    Measured: 48 hours

  6. BARC bleeding

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

    Measured: 48 hours

  7. Rate of Net Adverse Clinical Events (NACE)

    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

    Measured: 30 days

  8. Death

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

    Measured: 30 days

  9. Myocardial infarction

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

    Measured: 30 days

  10. Stroke

    Stroke will be evaluated at 30 days from index procedure

    Measured: 30 days

  11. Target Vessel Revascularization

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

    Measured: 30 days

  12. Definite or probable stent thrombosis

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

    Measured: 30 days

  13. BARC bleeding

    BARC bleeding will be evaluated at 30 days from index procedure

    Measured: 30 days

  14. Cardiac death

    Cardiac death will be evaluated at 48 hours from index procedure

    Measured: 48 hours

  15. Cardiac death

    Cardiac death will be evaluated at 30 days from index procedure

    Measured: 30 days

  16. Transition to oral P2Y12 inhibitors

    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

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2022
  2. Study start14 Mar 2022
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
717 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05193019
Sponsor's protocol ID
EPIC27-PATREAL
Acronym
PATREAL
Status last verified
Feb 2026
First submitted
31 Dec 2021
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.

    PubMed 32860058

  • Capodanno D, Ferreiro JL, Angiolillo DJ. Antiplatelet therapy: new pharmacological agents and changing paradigms. J Thromb Haemost. 2013 Jun;11 Suppl 1:316-29. doi: 10.1111/jth.12219.

    PubMed 23809135

  • Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimsky P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Genereux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013 Apr 4;368(14):1303-13. doi: 10.1056/NEJMoa1300815. Epub 2013 Mar 10.

    PubMed 23473369

  • Steg PG, Bhatt DL, Hamm CW, Stone GW, Gibson CM, Mahaffey KW, Leonardi S, Liu T, Skerjanec S, Day JR, Iwaoka RS, Stuckey TD, Gogia HS, Gruberg L, French WJ, White HD, Harrington RA; CHAMPION Investigators. Effect of cangrelor on periprocedural outcomes in percutaneous coronary interventions: a pooled analysis of patient-level data. Lancet. 2013 Dec 14;382(9909):1981-92. doi: 10.1016/S0140-6736(13)61615-3. Epub 2013 Sep 3.

    PubMed 24011551

  • Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

    PubMed 30165437

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Heart Disease and Acute Coronary Syndrome, run by Fundación EPIC at 12 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Net Adverse Clinical Events (NACE) (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05193019, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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