Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention

NCT04240834 | Recruiting Phase 4

• 1 other identifier: 2019XK320061
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.

Conditions

Acute Coronary Syndrome; Interventional Cardiology

Keywords

ACS; PCI; DAPI; Aspirin; Ticagrelor

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebral events (MACCEs)

  Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization

  12 months after randomization

Secondary Outcomes (4)

• Bleeding episode (Key secondary endpoint)

  12 months after randomization

• Platelet function

  12 months after randomization

• Medication adherence

  12 months after randomization

• Bleeding-related withdrawal

  12 months after randomization

Study Arms (2)

LD group

EXPERIMENTAL

Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months

Drug: Aspirin; Drug: Ticagrelor

Control group

ACTIVE COMPARATOR

Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months

Drug: Aspirin; Drug: Ticagrelor

Interventions

Aspirin DRUG

Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Also known as: Acetylsalicylic Acid

Control group; LD group

Ticagrelor DRUG

Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Also known as: Brilinta/Brilique

Control group; LD group

Eligibility Criteria

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

You may qualify if:

• ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent
• Able and willing to provide informed consent and participate in 12 months follow-up period
• Able to receive DAPT treatment

You may not qualify if:

• Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative \<55 years old or in first-degree female relative \<65 years old)
• Repeated myocardial infarction
• Positive serum cardiac troponin I/T
• Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)
• Type 2 diabetes mellitus under medication
• Chronic kidney disease (eGFR\<60 mL/min/1.73 m2 or CrCl\<60ml/min)
• LM lesion requiring stents
• Proximal LAD lesion(s) requiring stents
• Bypass grafts lesion(s) requiring stents
• Overall stent length ≥60 mm
• History of in-stent thrombosis
• Bifurcation lesions requiring at least 2 stents
• Over two vessels lesions requiring stents
• Calcified target lesion(s) requiring atherectomy
• The intraoperative occurrence of no-reflow or slow-flow

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Aspirin; 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; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Haiyan Qian, MD, PhD

  Fuwai Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Qian, MD, PhD

CONTACT

+8613811386143; ahqhy712@163.com

Zhiyao Wei

CONTACT

+8615521192379; weizhiyaoyx@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: February 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

CN (1)