Dual-blood thinner therapy options for elective PCI in a real-world setting

Dual-AntiPlatelet Therapy strategies FOR elective PCI in a REAL-world setting - DAPT for REAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006072-16-NL

Enrollment

1836

Registered

2022-08-06

Start date

2022-08-09

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease MedDRA version: 20.0 Level: LLT Classification code 10011079 Term: Coronary artery disease NOS System Organ Class: 100000004849

Interventions

Trade Name: Plavix Product Name: Plavix Product Code: B01AC04 Pharmaceutical Form: Film-coated tablet Trade Name: Plavix Product Name: Plavix Product Code: B01AC04 Pharmaceutical Form: Film-coated ta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult men and women aged at least 18 years - Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 936

Exclusion criteria

Exclusion criteria: - Contraindication to clopidogrel (e.g., hypersensitivity, active bleeding, history of previous intracranial bleed deemed unsuitable for dual antiplatelet therapy, gastrointestinal bleed within the past 6 months, major surgery within the past 4 weeks or planned major surgery within 3 months, severe hepatic insufficiency) - Use of other P2Y12 inhibitors - Use of oral anticoagulation (VKA or NOAC) - Active malignancies - Pregnancies or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and efficacy of in-laboratory 600mg clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel 75mg preloading treatment for 3 consecutive days in patients planned for diagnostic angiography with optional ad-hoc PCI.;Secondary Objective: To assess the difference in occurrence of the following events in patients who received an in-laboratory clopidogrel loading dose directly before ad-hoc PCI versus patients who received clopidogrel preloading treatment in the 3 days preceding diagnostic CAG with optional ad-hoc PCI: -BARC-2, -3 and -5 bleeding at 6 months -POCE at 30 days and 6 months -NACE at 6 months -Individual endpoints of the composite endpoints POCE / NACE at 30d and 6 months -Peri-procedural myocardial infarction ;Primary end point(s): Net Adverse Clinical Events (NACE);Timepoint(s) of evaluation of this end point: after 30 days	—

Measure

Time frame

Main Objective: To assess the safety and efficacy of in-laboratory 600mg clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel 75mg preloading treatment for 3 consecutive days in patients planned for diagnostic angiography with optional ad-hoc PCI.;Secondary Objective: To assess the difference in occurrence of the following events in patients who received an in-laboratory clopidogrel loading dose directly before ad-hoc PCI versus patients who received clopidogrel preloading treatment in the 3 days preceding diagnostic CAG with optional ad-hoc PCI: -BARC-2, -3 and -5 bleeding at 6 months -POCE at 30 days and 6 months -NACE at 6 months -Individual endpoints of the composite endpoints POCE / NACE at 30d and 6 months -Peri-procedural myocardial infarction ;Primary end point(s): Net Adverse Clinical Events (NACE);Timepoint(s) of evaluation of this end point: after 30 days

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Secondary

Measure	Time frame
Secondary end point(s): - BARC-2, -3 and -5 bleeding - Patient Oriented Clinical Events (POCE) - NACE - Individual endpoints of the composite endpoints POCE / NACE - Peri-procedural myocardial infarction;Timepoint(s) of evaluation of this end point: All secondary end points will be assessed after 30 days and after 6 months, with exception of periprocedural myocardial infarction, which will be assessed during index hospitalisation only.	—

Measure

Time frame

Secondary end point(s): - BARC-2, -3 and -5 bleeding - Patient Oriented Clinical Events (POCE) - NACE - Individual endpoints of the composite endpoints POCE / NACE - Peri-procedural myocardial infarction;Timepoint(s) of evaluation of this end point: All secondary end points will be assessed after 30 days and after 6 months, with exception of periprocedural myocardial infarction, which will be assessed during index hospitalisation only.

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Countries

Netherlands

Contacts

Public ContactRosanne Vogel

Amsterdam University Medical Center (AUMC)

r.f.vogel@amsterdamumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026