NCT04060914

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.

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
225

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2019

Typical duration 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

August 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

August 30, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

August 16, 2019

Last Update Submit

August 16, 2019

Conditions

Antiplatelet TherapyCoronary Artery DiseasePercutaneous Coronary Intervention

Keywords

ticagrelorclopidogrelPercutaneous Coronary InterventionCoronary Artery DiseaseAdenosine

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days (±14)

Secondary Outcomes (3)

  • Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)

    1 year

  • The platelet aggregation ratio

    90 days (±14)

  • Plasma adenosine concentration

    90 days (±14)

Study Arms (3)

Ticagrelor(90mg)

EXPERIMENTAL
Drug: Ticagrelor 90mg

Ticagrelor(90/60mg)

EXPERIMENTAL
Drug: Ticagrelor 90mg/60mg

Clopidogrel(75mg)

ACTIVE COMPARATOR
Drug: Clopidogrel 75mg

Interventions

Ticagrelor 90mgDRUG

Ticagrelor 90 mg plus aspirin for 12 months

Ticagrelor(90mg)
Ticagrelor 90mg/60mgDRUG

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

Ticagrelor(90/60mg)
Clopidogrel 75mgDRUG

Clopidogrel 75mg plus aspirin for 12 months

Clopidogrel(75mg)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Yi Zhang, PhD

CONTACT

86-010-64456609phd-zhangyi@outlook.com

Yang Lin, PhD

CONTACT

86-010-64456609linyang3623@outlook.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 19, 2019

Study Start

August 30, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2021

Last Updated

August 19, 2019

Record last verified: 2019-08

Locations

CN(1)