Pharmacodynamic and Short-term Effects of Half-dose Ticagrelor With or Without Aspirin vs DAPT From Day of PCI in CCS

NCT07622056 | Completed Phase 4 DMC

• 1 other identifier: KSVGH 23-CT12-07
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Six months of aspirin plus clopidogrel remains the recommended antiplatelet regimen after percutaneous coronary intervention (PCI) for chronic coronary syndrome (CCS), with the more potent P2Y₁₂ inhibitors reserved for the acute coronary syndromes (ACS) that produced their pivotal evidence. Yet the contemporary landscape of post-PCI antithrombotic therapy has shifted considerably since PLATO and TRITON-TIMI 38, and the conventional algorithm sits increasingly uneasily with two well-established realities. The first is the now consistent demonstration that aspirin contributes more to bleeding than to ischemic protection in patients adequately treated with a P2Y₁₂ inhibitor. TWILIGHT, TICO, T-PASS, ULTIMATE-DAPT and GLOBAL LEADERS have, in sequence, established that withdrawing aspirin after a defined period of P2Y₁₂-based DAPT reduces clinically relevant bleeding without an excess of ischemic events. Each of these trials, however, retained ticagrelor at the standard 90 mg twice-daily dose, required a run-in of conventional DAPT before aspirin was stopped, and enrolled populations dominated by ACS. The second is the persistent and now mechanistically grounded observation that East-Asian patients tolerate less antithrombotic intensity than the Caucasian populations on whom dose recommendations were calibrated. Ticagrelor exposure is higher in East-Asian patients, baseline platelet reactivity is lower, and the bleeding-to-ischemia ratio is shifted relative to PLATO-era expectations. Pharmacokinetic and pharmacodynamic work in Chinese and Japanese cohorts has shown that ticagrelor 45 mg twice daily - half the standard maintenance dose - yields platelet inhibition statistically indistinguishable from the 90 mg regimen. No randomised trial has yet tested an aspirin-free, half-dose ticagrelor monotherapy strategy initiated at the index PCI in CCS patients. The closest registered protocol of which we are aware (NCT07080684) uses ticagrelor 60 mg twice daily following a one-month DAPT lead-in, with a two-arm design. We therefore conducted a three-arm randomised pilot trial in East-Asian CCS patients to compare standard DAPT, DAPT with half-dose ticagrelor, and aspirin-free half-dose ticagrelor monotherapy from the day of PCI, using the change in P2Y₁₂ reaction units (PRU) as the primary pharmacodynamic readout and twelve-month clinical events as exploratory endpoints.

Conditions

Coronary Heart Disease

Keywords

Coronary Heart disease, Half dose Ticagrelor monotherapy

Outcome Measures

Primary Outcomes (2)

• Change in P2Y12 reaction units (PRU) from baseline to follow-up (VerifyNow P2Y12 assay)

  P2Y12 reaction units (PRU) are follow up before randomization and at 14 days after randomization

• Change in P2Y12 reaction units (PRU) from baseline to follow-up (VerifyNow P2Y12 assay)

  Platelet reactivity was assessed with the VerifyNow P2Y₁₂ point-of-care assay on whole-blood samples drawn at two time points: before the index loading dose, and at a median of seventeen days after PCI. Results are expressed in PRU. High platelet reactivity was pre-specified as PRU ≥ 208 and very low reactivity as PRU \< 85

  Enrolled patient from Jan 1, 2024 to Dec 31 2024, and all patient received at 1 year complete follow up

Study Arms (3)

Arm 1 (Control)

PLACEBO COMPARATOR

Aspirin 100 mg + clopidogrel (300 mg load → 75 mg daily) ×6 months, then aspirin monotherapy

Drug: Aspirin 100 mg + clopidogrel (300 mg load → 75 mg daily) ×6 months, then aspirin monotherapy

Arm 2 (Experimental A)

PLACEBO COMPARATOR

Arm 2 (aspirin plus half-dose ticagrelor): aspirin 100 mg plus a 180 mg ticagrelor loading dose; then aspirin 100 mg plus ticagrelor 45 mg twice daily for six months, followed by aspirin 100 mg monotherapy.

Drug: Aspirin 100 mg + ticagrelor (90 mg load → 45 mg twice daily) ×6 months, then aspirin monotherapy

Arm 3 (Experimental B)

EXPERIMENTAL

Ticagrelor (90 mg load → 45 mg twice daily) monotherapy; aspirin stopped at day 2 after randomization; continued indefinitely

Drug: Ticagrelor (90 mg load → 45 mg twice daily) monotherapy; aspirin stopped at day 2 after randomisation; continued indefinitely

Interventions

Aspirin 100 mg + ticagrelor (90 mg load → 45 mg twice daily) ×6 months, then aspirin monotherapy DRUG

Aspirin 100 mg + ticagrelor (90 mg load → 45 mg twice daily) ×6 months, then aspirin monotherapy

Arm 2 (Experimental A)

Aspirin 100 mg + clopidogrel (300 mg load → 75 mg daily) ×6 months, then aspirin monotherapy DRUG

Aspirin 100 mg + clopidogrel (300 mg load → 75 mg daily) ×6 months, then aspirin monotherapy

Arm 1 (Control)

Ticagrelor (90 mg load → 45 mg twice daily) monotherapy; aspirin stopped at day 2 after randomisation; continued indefinitely DRUG

Ticagrelor (90 mg load → 45 mg twice daily) monotherapy; aspirin stopped at day 2 after randomisation; continued indefinitely

Arm 3 (Experimental B)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults with CCS, defined per the 2019 ESC criteria, scheduled for elective PCI on the day after admission
• able to provide consent

You may not qualify if:

• ACS at presentation
• Prior intolerance to any study drug
• Active bleeding or BARC ≥ 3 bleeding within three months,
• NYHA IV heart failure
• Platelet count below 100 × 10⁹/L
• eGFR below 30 mL/min/1.73 m²
• Severe hepatic dysfunction
• Planned non-cardiac surgery within twelve months
• Patient who inabley to provide consent.
• Patients in whom PCI was not performed at the index procedure (per protocol)

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813414, Taiwan

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Aspirin; Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Feng Yu Kuo, PhD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of cardiovascular center, KSVGH

Model Details: Randomized, Parallel assignment (three-arm, 1:1:1)

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: January 3, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: started once the result was publicised for 1 year
• Access Criteria: The researcher, surveyed by all authors, with reasonable request, and if all authors agreed, data will be accessed. they will get the data from Chief Feng Yu Kuo via e-mail

Locations

TW (1)