NCT04307485

Brief Summary

In this study, the investigates try to confirm our hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in senior （no less than 75 years old)acute coronary syndrome patients . Totally 40 senior ACS patients will be divided into 2 groups randomly one month after PCI . Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group 2 will be treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment. The platelets function will be tested in VASP and TEG methods 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

March 8, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

4.2 years

First QC Date

March 8, 2020

Last Update Submit

October 5, 2023

Conditions

Senior Acute Coronary Syndrome Patients After PCI

Outcome Measures

Primary Outcomes (2)

  • changes of PRI detected by VASP methods

    platelet reactivity index (PRI) detected by VASP (Vasodilator Stimulated

    changes of PRI from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI

  • changes of Maximum Amplitude (MA) detected by TEG

    Maximum Amplitude (MA) detected by TEG(Thromboelastography)

    changes of MA from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI

Study Arms (2)

standard dose ticargrelor based DAPT therapy

ACTIVE COMPARATOR

treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group

Drug: Ticagrelor

low dose ticargrelor based DAPT

EXPERIMENTAL

treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment

Drug: Ticagrelor

Interventions

TicagrelorDRUG

90mg ticargrelor based DAPT vs 60mg ticargrelor based DAPT

low dose ticargrelor based DAPTstandard dose ticargrelor based DAPT therapy

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subject must be at least 75 years of age 2 Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3.Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure

You may not qualify if:

  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  • Active bleeding
  • Known hypersensitivity or contraindication to study medications
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  • Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Subjects with Cerebral hemorrhage history
  • Subjects with stroke history in half a year
  • subjects with active malignant tumor
  • subjects with whom oral anticoagulants are needed
  • Other conditions which the investigators think not applicable to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

shanghai Tongren hospital

Shanghai, Shanghai Municipality, 200336, China

RECRUITING

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Lei Hou, Doctor

CONTACT

13564868096Dr_houlei@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 13, 2020

Study Start

March 10, 2020

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

CN(1)