Clinical trial NCT04060914: LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention
Official title: LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antiplatelet Therapy
Coronary Artery Disease
Percutaneous Coronary Intervention
Keywords: ticagrelor
clopidogrel
Percutaneous Coronary Intervention
Coronary Artery Disease
Adenosine
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogrel for patients with ACS after PCI.


Eligibility criteria: Inclusion Criteria:

* Agree to sign the Informed Consent;
* Male or female, ≥ 18 years of age, and ≤ 70 years of age
* Patient presents with acute coronary syndrome (ACS)
* Planned to undergo PCI
* Planned to DAPT for 1 year after PCI

Exclusion Criteria:

* Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
* Patients cannot use ticagrelor or clopidogrel due to contraindications or other reasons.
* Patients with active pathological hemorrhage or a history of intracranial hemorrhage
* Patient unable to receive 12 months of dual anti-platelet therapy
* Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI
* Patient or physician refusal to enroll in the study
* History of intracranial hemorrhage
* Patient has a history of bleeding diathesis or coagulopathy
* Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
* Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months
* Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
* Patient with cardiogenic shock or mechanical circulatory assist devices placed
* Patient with active liver diseases
* Patient with severe renal insufficiency (eGFR \<30ml/min/1.73m2 based on simplified MDRD equation or CrCl \<30ml/min based on Cockcroft-Gault equation)
* Patient has a malignancy or a life expectancy of less than one year
* Platelet count \<100 000/μL, or hematocrit \<32% or \>52%, or white blood cell count \<3000/μL
* Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor

Primary outcomes:
measure: Platelet reactivity index (PRI)
timeFrame: 90 days (±14)
Secondary outcomes:
measure: Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: 1 year
measure: The platelet aggregation ratio
timeFrame: 90 days (±14)
measure: Plasma adenosine concentration
timeFrame: 90 days (±14)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References: