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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)

Primary Purpose

Acute Coronary Syndrome, Interventional Cardiology

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Aspirin

Ticagrelor

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring ACS, PCI, DAPI, Aspirin, Ticagrelor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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
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

Sites / Locations

Fuwai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LD group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bleeding episode (Key secondary endpoint)

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)

Platelet function

Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)

Medication adherence

Bleeding-related withdrawal

Full Information

NCT ID

NCT04240834

First Posted

January 22, 2020

Last Updated

January 22, 2020

Sponsor

Fu Wai Hospital, Beijing, China

1. Study Identification

Unique Protocol Identification Number

NCT04240834

Brief Title

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

Acronym

LD-ASPIRIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 2020 (Anticipated)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fu Wai Hospital, Beijing, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Interventional Cardiology

Keywords

ACS, PCI, DAPI, Aspirin, Ticagrelor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LD group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aspirin

Other Intervention Name(s)

Acetylsalicylic Acid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Other Intervention Name(s)

Brilinta/Brilique

Intervention Description

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

Primary Outcome Measure Information:

Title

Major adverse cardiac and cerebral events (MACCEs)

Description

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

Time Frame

12 months after randomization

Secondary Outcome Measure Information:

Title

Bleeding episode (Key secondary endpoint)

Description

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)

Time Frame

12 months after randomization

Title

Platelet function

Description

Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)

Time Frame

12 months after randomization

Title

Medication adherence

Time Frame

12 months after randomization

Title

Bleeding-related withdrawal

Time Frame

12 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haiyan Qian, MD, PhD

Phone

+8613811386143

ahqhy712@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhiyao Wei

Phone

+8615521192379

weizhiyaoyx@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haiyan Qian, MD, PhD

Organizational Affiliation

Fuwai Hospital, Beijing, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Hospital

City

Beijing

State/Province

Beijing

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haiyan Qian, MD, PhD

Phone

+8613811386143

ahqhy712@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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