NCT01962428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 9, 2016

Completed
Last Updated

November 9, 2016

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

October 10, 2013

Results QC Date

September 21, 2016

Last Update Submit

September 21, 2016

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Keywords

ticagrelorloading dosenon-ST-segment elevation acute coronary syndromespercutaneous coronary interventionthe antiplatelet effectsbleeding eventsmajor adverse cardiac events

Outcome Measures

Primary Outcomes (1)

  • 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).

    2 hours after the loading dose of ticagrelor

Secondary Outcomes (2)

  • Platelet Reactivity Index (PRI) Measured by VASP-P

    0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor

  • Bleeding Events

    follow-up for 28 days after the loading dose of ticagrelor

Study Arms (2)

high loading dose of ticagrelor

EXPERIMENTAL

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

Drug: ticagrelor

conventional loading dose of ticagrelor

ACTIVE COMPARATOR

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

Drug: ticagrelor

Interventions

ticagrelorDRUG

Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Also known as: Brilinta
conventional loading dose of ticagrelorhigh loading dose of ticagrelor

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Hospital of Chinese People's Armed Police Forces

Beijing, Beijing Municipality, 100039, China

Location

General Hospital of Chinese People's Armed Police Forces

Beijing, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
huiliang Liu
Organization
General Hospital of Chinese People's Armed Police Forces
lhl518@vip.sina.com
+8601057976707

Study Officials

  • Huiliang Liu, Doctor

    Department of Cardiology of General Hospital of Chinese People's Armed Police Forces

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 14, 2013

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 9, 2016

Results First Posted

November 9, 2016

Record last verified: 2015-12

Locations

CN(2)