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LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention (LOTIC)

Primary Purpose

Antiplatelet Therapy, Coronary Artery Disease, Percutaneous Coronary Intervention

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ticagrelor 90mg

Ticagrelor 90mg/60mg

Clopidogrel 75mg

About this trial

This is an interventional treatment trial for Antiplatelet Therapy focused on measuring ticagrelor, clopidogrel, Percutaneous Coronary Intervention, Coronary Artery Disease, Adenosine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Anzhen Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor(90mg)

Ticagrelor(90/60mg)

Clopidogrel(75mg)

Arm Description

Outcomes

Primary Outcome Measures

Platelet reactivity index (PRI)

Platelet reactivity of ticagrelor or clopidogrel MD will be measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP) at 90 days after PCI.

Secondary Outcome Measures

Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)

MACCE includes all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization.

The platelet aggregation ratio

Platelet aggregation of ticagrelor or clopidogrel MD will be measured using the Light Transmittance Aggregometry method at day 90 after PCI.

Plasma adenosine concentration

Plasma adenosine concentration in the three treatment groups will be measured using the HPLC-MS at day 90 after PCI.

Full Information

NCT ID

NCT04060914

First Posted

August 16, 2019

Last Updated

August 16, 2019

Sponsor

Beijing Anzhen Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04060914

Brief Title

LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Acronym

LOTIC

Official Title

LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 30, 2019 (Anticipated)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Antiplatelet Therapy, Coronary Artery Disease, Percutaneous Coronary Intervention

Keywords

ticagrelor, clopidogrel, Percutaneous Coronary Intervention, Coronary Artery Disease, Adenosine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ticagrelor(90mg)

Arm Type

Experimental

Arm Title

Ticagrelor(90/60mg)

Arm Type

Experimental

Arm Title

Clopidogrel(75mg)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Ticagrelor 90mg

Intervention Description

Ticagrelor 90 mg plus aspirin for 12 months

Intervention Type

Drug

Intervention Name(s)

Ticagrelor 90mg/60mg

Intervention Description

1 month after treatment with ticagrelor 90 mg plus aspirin, followed by treatment with ticagrelor 60 mg plus aspirin for 11 months

Intervention Type

Drug

Intervention Name(s)

Clopidogrel 75mg

Intervention Description

Clopidogrel 75mg plus aspirin for 12 months

Primary Outcome Measure Information:

Title

Platelet reactivity index (PRI)

Description

Platelet reactivity of ticagrelor or clopidogrel MD will be measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP) at 90 days after PCI.

Time Frame

90 days (±14)

Secondary Outcome Measure Information:

Title

Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)

Description

MACCE includes all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization.

Time Frame

1 year

Title

The platelet aggregation ratio

Description

Platelet aggregation of ticagrelor or clopidogrel MD will be measured using the Light Transmittance Aggregometry method at day 90 after PCI.

Time Frame

90 days (±14)

Title

Plasma adenosine concentration

Description

Plasma adenosine concentration in the three treatment groups will be measured using the HPLC-MS at day 90 after PCI.

Time Frame

90 days (±14)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

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

Yi Zhang, PhD

Phone

86-010-64456609

phd-zhangyi@outlook.com

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

Yang Lin, PhD

Phone

86-010-64456609

linyang3623@outlook.com

Facility Information:

Facility Name

Beijing Anzhen Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yang Lin, PhD

Phone

86-010-64456609

linyang3623@outlook.com

First Name & Middle Initial & Last Name & Degree

Xiujing Shi, MD

Phone

86-010-64456609

xiujingshi@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

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