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Reversal of the Anti-platelet Effects of Ticagrelor (REVERSAL)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ticagrelor
Aspirin + Ticagrelor
Control
Aspirin + Ticagrelor
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Ticagrelor, Aspirin, Peri-operative treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Cohort 1:

Inclusion Criteria:

  • Healthy volunteers;
  • Subjects aged >18 years old;

Exclusion Criteria:

  • Allergy or intolerance to aspirin or ticagrelor;
  • Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L);
  • Subjects with anemia;
  • Subjects with bronchial asthma or chronic obstructive pulmonary disease;
  • Subjects with bradycardia (e.g. sick sinus syndrome, high-grade atrioventricular block, history of syncope with unproved uncorrelation with bradycardia);
  • Smokers;
  • Subjects with diabetes mellitus;
  • Subjects planning to be pregnancy;
  • Subjects with hepatic or renal dysfunction;
  • Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period.

Cohort 2:

Inclusion Criteria:

  • Subjects with diagnosed coronary artery disease undergoing percutaneous coronary intervention (PCI);
  • Subjects who have received dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily) for 7 days;

Exclusion Criteria:

  • Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L);
  • Subjects with anemia;
  • Smokers
  • Subjects planning to be pregnancy;
  • Subjects with hepatic or renal dysfunction;
  • Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period.

Sites / Locations

  • First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Other

Arm Label

Single Anti-platelet Treatment

Dual Anti-platelet Treatment

Control

CAD undergoing PCI

Arm Description

Ticagrelor

Aspirin + Ticagrelor

No Drug

Patients with coronary artery disease undergoing percutaneous coronary intervention and receiving dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily)

Outcomes

Primary Outcome Measures

Reversal of the platelet inhibitory effects of antiplatelet therapy in healthy volunteers
Proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of antiplatelet therapy
Reversal of the platelet inhibitory effects of antiplatelet therapy in patients
Reversal of the platelet inhibitory effects of antiplatelet therapy Proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of antiplatelet therapy in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving ticagrelor

Secondary Outcome Measures

Inhibition of platelet aggregation in response to AA or ADP
Inhibition of platelet aggregation (IPA) in response to 5μM ADP determined by light transmittance aggregometer (LTA) after 7-day ticagrelor administration
Change of ADP-induced platelet aggregation in platelets saved in blood bank due to the saving time
How the ADP-induced platelet aggregation in platelets saved in blood bank changes due to the saving time

Full Information

First Posted
February 5, 2015
Last Updated
August 14, 2017
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT02383771
Brief Title
Reversal of the Anti-platelet Effects of Ticagrelor
Acronym
REVERSAL
Official Title
Reversal of the Anti-platelet Effects of Ticagrelor in Healthy Persons and Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of ticagrelor and aspirin in healthy persons and patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving ticagrelor.
Detailed Description
Reversal of the Anti-platelet Effects of Ticagrelor: REVERSAL study The fatality of stent thrombosis (ST) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) is approximately 50% and clopidogrel is an important anti-platelet drug for prevention of ST. CAD patients implanted with stent including bare metal stent (BMS) and drug eluting stent (DES) are recommended to receive dual anti-platelet treatment (DAPT), i.e. clopidogrel along with aspirin, for at least one year to reduce the incidence of ST by up-to-date guidelines. However, due to the variability of anti-platelet effect of clopidogrel, regular dose (75 mg daily) of clopidogrel administered cannot achieve enough inhibition of platelet aggregation in 20-30% of total patients, which is named as clopidogrel low responsiveness (CLR), and the morbidity of thrombosis (including) in CAD patients is still 10%. Ticagrelor, a cyclopentyl-triazolo-pyrimidine, is a more potent adenosine diphosphate (ADP) receptor antagonist with faster onset and more significantly higher inhibition of platelet aggregation compared with clopidogrel and directly acts on P2Y12-ADP receptor in platelets without process of hepatic metabolism. In the PLATO study, ticagrelor plus reduced the remarkable incidence of cardiovascular events in patients with acute coronary syndrome (ACS) without significant higher incidence of major bleeding events compared with clopidogrel plus aspirin. Surprisingly, the incidence of death due to cardiovascular causes and the total fatality was decreased in patients with ticagrelor plus aspirin compared with those with clopidogrel plus aspirin. The results suggested the more benefit brought by ticagrelor, highlighting the wide use of it in the future. Due to the potent anti-platelet effect of ticagrelor, more bleeding events may occur. Additionally, when facing the need for cardiac or non-cardiac operation, occurrence of life-threatening bleeding event or necessity of emergency operation, doctors may be confused of the treatment for the patients taking ticagrelor, of which the half-life period is 8-9 hours and it suggests the importance of studying the reversal of the anti-platelet effects of ticagrelor. The primary objective of this study is to investigate the proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of aspirin and ticagrelor in healthy persons and patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving ticagrelor. Study Population: The investigators design two cohort studies, and plan to enroll 32 healthy volunteers in cohort 1 and 16 patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily) for 7 days Cohort 1: Randomization: A total of 32 healthy volunteers are planned to be enrolled and will be randomly divided into three groups: single anti-platelet treatment group (A group, 8 of 32), dual anti-platelet treatment group (B group, 8 of 32) and control group (C group, 16 of 32). Single anti-platelet treatment group: (Ticagrelor 90mg bid) × 7 days Dual anti-platelet treatment group: (Ticagrelor 90mg bid + Aspirin 100mg daily) × 7 days Control group: No anti-platelet therapy Inclusion criteria: Healthy volunteers Participants aged >18 years old Exclusion criteria: Allergy or intolerance to aspirin or ticagrelor; Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L); Subjects with bronchial asthma or chronic obstructive pulmonary disease; Subjects with bradycardia (e.g. sick sinus syndrome, high-grade atrioventricular block, history of syncope with unproved uncorrelation with bradycardia); Smokers; Subjects with diabetes mellitus; Subjects planning to be pregnancy; Subjects with hepatic or renal dysfunction; Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period. Blood collection and sample preparation Venous blood samples are collected by venipuncture into two 4.5-mL draw BD vacutainer tubes containing 0.105M buffered sodium citrate (3.2%) at 08.00 hours in the morning before taking the agent and after the last dose of the study drug. Platelet-rich plasma (PRP) from subjects in A group is mixed with increasing proportions of that in C group, with one untreated subject serving as the control for one treated subject. The proportion of control platelets mixed with inhibited platelets is calculated based on platelet numbers, starting at 10% and increasing by 10% increments. So as the PRP in B group. Test: Before taking the agent: ADP-induced platelet aggregation: light transmittance aggregation (LTA) in response to 5μM ADP Arachidonic acid (AA)-induced platelet aggregation: LTA in response to 1mM AA After 7-day medication: ADP-induced platelet aggregation: LTA in response to 5μM ADP AA-induced platelet aggregation: LTA in response to 1mM AA ADP-induced platelet aggregation of mixed sample: LTA in response to 5μM ADP AA-induced platelet aggregation of mixed sample: LTA in response to 1mM AA Primary end points: 1. Reversal of the platelet inhibitory effects of antiplatelet therapy Proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of antiplatelet therapy in healthy volunteers Secondary end points: 1. Inhibition of platelet aggregation (IPA) in response to 5μM ADP determined by light transmittance aggregometer (LTA) after 7-day ticagrelor administration Safety issue: No Cohort 2: A total of 16 patients with diagnosed coronary artery disease who have undergone percutaneous coronary intervention (PCI) and have received dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily) for 7 days is planned to be enrolled. Inclusion Criteria: Subjects with diagnosed coronary artery disease undergoing percutaneous coronary intervention (PCI); Subjects who have received dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily) for 7 days; Exclusion Criteria: Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L); Subjects with anemia; Smokers Subjects planning to be pregnancy; Subjects with hepatic or renal dysfunction; Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period. Sample test for fresh platelet saved in blood bank Function of platelet aggregation, platelet count, pH value and metabolic products (including PO2, PCO2, blood glucose, lactate, bicarbonate, sodium, potassium and chloride) are measured in fresh platelet sample preserved in blood bank for 1, 2, 3, 4, and 5 days respectively. Blood collection and sample preparation for patients Venous blood samples are collected by venipuncture into two 4.5-mL draw BD vacutainer tubes containing 0.105M buffered sodium citrate (3.2%) at 08.00 hours in the morning after taking the medicine. Platelet-rich plasma (PRP) from participants is mixed with increasing proportions of that extracted from fresh platelet sample reserved in blood bank for one day as the control for each treated subject. The proportion of control platelets mixed with inhibited platelets is calculated based on platelet numbers, starting at 10% and increasing by 10% increments. So as the PRP mixed with fresh platelet sample preserved for four days. Test for sample from patients Before mixture: ADP-induced platelet aggregation: light transmittance aggregation (LTA) in response to 5μM ADP Arachidonic acid (AA)-induced platelet aggregation: LTA in response to 1mM AA After mixture: ADP-induced platelet aggregation: LTA in response to 5μM ADP AA-induced platelet aggregation: LTA in response to 1mM AA Primary end points: 1. Reversal of the platelet inhibitory effects of antiplatelet therapy Proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of antiplatelet therapy in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving ticagrelor Secondary end points: 1. Relationship between function of platelet aggregation and the time of saving fresh platelet. Safety issue: No

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Ticagrelor, Aspirin, Peri-operative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Anti-platelet Treatment
Arm Type
Experimental
Arm Description
Ticagrelor
Arm Title
Dual Anti-platelet Treatment
Arm Type
Experimental
Arm Description
Aspirin + Ticagrelor
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
No Drug
Arm Title
CAD undergoing PCI
Arm Type
Other
Arm Description
Patients with coronary artery disease undergoing percutaneous coronary intervention and receiving dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily)
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilinta
Intervention Description
(Ticagrelor 90mg Bid) x 7days
Intervention Type
Drug
Intervention Name(s)
Aspirin + Ticagrelor
Other Intervention Name(s)
Brilinta
Intervention Description
(Aspirin 100mg daily + Ticagrelor 90mg Bid) x 7days
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
No Anti-platelet Therapy
Intervention Type
Drug
Intervention Name(s)
Aspirin + Ticagrelor
Other Intervention Name(s)
Brilinta
Intervention Description
Dual anti-platelet therapy (Aspirin 100mg daily + Ticagrelor 90mg Bid) after percutaneous coronary intervention (PCI)
Primary Outcome Measure Information:
Title
Reversal of the platelet inhibitory effects of antiplatelet therapy in healthy volunteers
Description
Proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of antiplatelet therapy
Time Frame
7 days after randomization
Title
Reversal of the platelet inhibitory effects of antiplatelet therapy in patients
Description
Reversal of the platelet inhibitory effects of antiplatelet therapy Proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of antiplatelet therapy in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving ticagrelor
Time Frame
7 days after percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
Inhibition of platelet aggregation in response to AA or ADP
Description
Inhibition of platelet aggregation (IPA) in response to 5μM ADP determined by light transmittance aggregometer (LTA) after 7-day ticagrelor administration
Time Frame
7 days after randomization
Title
Change of ADP-induced platelet aggregation in platelets saved in blood bank due to the saving time
Description
How the ADP-induced platelet aggregation in platelets saved in blood bank changes due to the saving time
Time Frame
5 days after fresh platelet collected and stored in blood bank

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Cohort 1: Inclusion Criteria: Healthy volunteers; Subjects aged >18 years old; Exclusion Criteria: Allergy or intolerance to aspirin or ticagrelor; Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L); Subjects with anemia; Subjects with bronchial asthma or chronic obstructive pulmonary disease; Subjects with bradycardia (e.g. sick sinus syndrome, high-grade atrioventricular block, history of syncope with unproved uncorrelation with bradycardia); Smokers; Subjects with diabetes mellitus; Subjects planning to be pregnancy; Subjects with hepatic or renal dysfunction; Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period. Cohort 2: Inclusion Criteria: Subjects with diagnosed coronary artery disease undergoing percutaneous coronary intervention (PCI); Subjects who have received dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily) for 7 days; Exclusion Criteria: Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L); Subjects with anemia; Smokers Subjects planning to be pregnancy; Subjects with hepatic or renal dysfunction; Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunjian Li, Ph.D
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

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Reversal of the Anti-platelet Effects of Ticagrelor

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