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

January 22, 2020 updated by: Qian Haiyan, Fu Wai Hospital, Beijing, China

Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Prospective, Randomized, Open-label, Blinded-endpoint Evaluation,Single-center, Phase 3 Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.

Study Type

Interventional

Enrollment (Anticipated)

1220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Haiyan Qian, MD, PhD
  • Phone Number: +8613811386143
  • Email: ahqhy712@163.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Fuwai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Enrollment into the study will require meeting at least one angiographic inclusion and none of the exclusion criteria.

Angiographic Inclusion Criteria:

  1. LM lesion requiring stents
  2. Proximal LAD lesion(s) requiring stents
  3. Bypass grafts lesion(s) requiring stents
  4. Overall stent length ≥60 mm
  5. History of in-stent thrombosis
  6. Bifurcation lesions requiring at least 2 stents
  7. Over two vessels lesions requiring stents
  8. Calcified target lesion(s) requiring atherectomy
  9. The intraoperative occurrence of no-reflow or slow-flow
  10. Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3)

Exclusion Criteria:

  • Need for chronic oral anticoagulation
  • With cardiomyopathy（HCM/DCM/RCM）
  • With severe ventricular arrhythmia requiring ICD implantation
  • With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease)
  • With severe infectious disease（active hepatitis B, active hepatitis C, AIDS）
  • With hematological disorders（thrombocytopenia, severe anemia, leukaemia）
  • With severe liver disease or kidney failure
  • With malignant tumor
  • With cognitive impairment
  • Unable or unwilling to provide informed consent or undergo follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LD group
Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months
Drug: Aspirin
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Other Names:
  • Acetylsalicylic Acid
Drug: Ticagrelor
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Other Names:
  • Brilinta/Brilique
ACTIVE_COMPARATOR: Control group
Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months
Drug: Aspirin
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Other Names:
  • Acetylsalicylic Acid
Drug: Ticagrelor
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Other Names:
  • Brilinta/Brilique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebral events (MACCEs)
Time Frame: 12 months after randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding episode (Key secondary endpoint)
Time Frame: 12 months after randomization
Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2)
12 months after randomization
Platelet function
Time Frame: 12 months after randomization
Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)
12 months after randomization
Medication adherence
Time Frame: 12 months after randomization
12 months after randomization
Bleeding-related withdrawal
Time Frame: 12 months after randomization
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Wai Hospital, Beijing, China

Investigators

  • Principal Investigator: Haiyan Qian, MD, PhD, Fuwai Hospital, Beijing, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2020

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (ACTUAL)

January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019XK320061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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