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Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

Primary Purpose

Non ST Segment Elevation Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ticagrelor
Sponsored by
General Hospital of Chinese Armed Police Forces
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non ST Segment Elevation Acute Coronary Syndrome focused on measuring ticagrelor, loading dose, non-ST-segment elevation acute coronary syndromes, percutaneous coronary intervention, the antiplatelet effects, bleeding events, major adverse cardiac events

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.
  • Male or non-pregnant female; aged from 18 to 80 years old.
  • Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.

Exclusion Criteria:

  • Any contraindication against the use of ticagrelor.
  • On treatment with a P2Y12 receptor antagonist in past 30 days.
  • Known allergies to aspirin or ticagrelor.
  • On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
  • Known blood dyscrasia or bleeding diathesis.
  • ST-segment elevation acute myocardial infarction.
  • Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
  • Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.

Sites / Locations

  • General Hospital of Chinese People's Armed Police Forces
  • General Hospital of Chinese People's Armed Police Forces

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high loading dose of ticagrelor

conventional loading dose of ticagrelor

Arm Description

Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

Outcomes

Primary Outcome Measures

Platelet Reactivity Index(PRI) Measured by VASP-P
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).

Secondary Outcome Measures

Platelet Reactivity Index (PRI) Measured by VASP-P
Bleeding Events

Full Information

First Posted
October 10, 2013
Last Updated
September 21, 2016
Sponsor
General Hospital of Chinese Armed Police Forces
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1. Study Identification

Unique Protocol Identification Number
NCT01962428
Brief Title
Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
Official Title
Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Chinese Armed Police Forces

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.
Detailed Description
After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 2h-72h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non ST Segment Elevation Acute Coronary Syndrome
Keywords
ticagrelor, loading dose, non-ST-segment elevation acute coronary syndromes, percutaneous coronary intervention, the antiplatelet effects, bleeding events, major adverse cardiac events

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high loading dose of ticagrelor
Arm Type
Experimental
Arm Description
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
Arm Title
conventional loading dose of ticagrelor
Arm Type
Active Comparator
Arm Description
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
Intervention Type
Drug
Intervention Name(s)
ticagrelor
Other Intervention Name(s)
Brilinta
Intervention Description
Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
Primary Outcome Measure Information:
Title
Platelet Reactivity Index(PRI) Measured by VASP-P
Description
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).
Time Frame
2 hours after the loading dose of ticagrelor
Secondary Outcome Measure Information:
Title
Platelet Reactivity Index (PRI) Measured by VASP-P
Time Frame
0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor
Title
Bleeding Events
Time Frame
follow-up for 28 days after the loading dose of ticagrelor

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent prior to any study specific procedures. Male or non-pregnant female; aged from 18 to 80 years old. Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI. Exclusion Criteria: Any contraindication against the use of ticagrelor. On treatment with a P2Y12 receptor antagonist in past 30 days. Known allergies to aspirin or ticagrelor. On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban). Known blood dyscrasia or bleeding diathesis. ST-segment elevation acute myocardial infarction. Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography. Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiliang Liu, Doctor
Organizational Affiliation
Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Chinese People's Armed Police Forces
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
General Hospital of Chinese People's Armed Police Forces
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

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