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 Randomized Controlled Study

Who is this study for? Patients with Acute Coronary Syndrome
What treatments are being studied? Aspirin+Ticagrelor
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 or clinical inclusion and none of the exclusion criteria.

∙ Clinical inclusion criteria:

⁃ 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)

∙ 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)

Locations
Other Locations
China
Fuwai Hospital
RECRUITING
Beijing
Contact Information
Primary
Haiyan Qian, MD, PhD
ahqhy712@163.com
+8613811386143
Backup
Zhiyao Wei
weizhiyaoyx@163.com
+8615521192379
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 1220
Treatments
Experimental: LD group
Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months
Active_comparator: Control group
Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months
Sponsors
Leads: Fu Wai Hospital, Beijing, China

This content was sourced from clinicaltrials.gov

Similar Clinical Trials