NCT03577652

Brief Summary

The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 10, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
Last Updated

July 5, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 20, 2018

Last Update Submit

July 2, 2018

Conditions

Coronary Artery DiseaseTicagrelor

Keywords

TicagrelorClopidogrelSwitching strategy

Outcome Measures

Primary Outcomes (1)

  • Platelet function assessments

    The primary endpoint was the comparations between the three projects for the value changes of maximal platelet aggregation (MPA) measured by Light Transmittance Aggregometry (LTA) at 2 hours after switching strategies.

    7 Days

Study Arms (3)

Ticagrelor, 90mg, 12h

EXPERIMENTAL
Drug: Ticagrelor

Ticagrelor, 90mg, 24h

EXPERIMENTAL
Drug: Ticagrelor

Ticagrelor, 180mg, 24h

EXPERIMENTAL
Drug: Ticagrelor

Interventions

TicagrelorDRUG

Ticagrelor, 90mg, 90mg twice daily

Ticagrelor, 180mg, 24hTicagrelor, 90mg, 12hTicagrelor, 90mg, 24h

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-75
  • Patients with complexity of CAD determined by coronary angiography and implanted stent successfully
  • Taking clopidogrel 75mg daily over 5 days or paients never took clopidogrel previously should receive 300-600mg drugs at least 12 hours before coronary angiography
  • Agreeing to participate in this trial and signed the written informed consent.

You may not qualify if:

  • They contraindicated with ticagrelor (including: allergying to ticagrelor or its active metabolite
  • Concomitanting therapy with a strong cytochrome P-450 3A inhibitor or inducer
  • Previous intracranial haemorrhage or ongoing bleeds
  • Moderate or severe hepatic impairment)
  • Having a previous medication with ticagrelor or long term anticoagulation
  • Having a history of asthma or chronic obstructive pulmonary disease (COPD) and recurrent attacked
  • Having an uncontrolled hypertension\>180/110mmHg
  • Having a hemoglobin\<100g/L 9.Having a platelet counts\<100Ă—10\^9/L
  • Having severe renal impairment (clearance\<30mL/min)
  • Having a history of hepaein-induced thrombocytopenia (HIT)
  • Having a pregnancy or were during lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110016, China

Location

Related Publications (1)

  • Yao Y, Wang P, Wang XZ, Zhao X, Zhao W, Zhou TN, Zhang L. Optimal strategy of switching from clopidogrel to ticagrelor in Chinese acute coronary syndrome patients with complicated coronary artery disease: the switching from clopidogrel to ticagrelor (SHIFT-CACS) study. Chin Med J (Engl). 2019 Oct 5;132(19):2292-2299. doi: 10.1097/CM9.0000000000000444.

    PMID: 31567375DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor

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 NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Hospital of Shenyang Military Region

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 5, 2018

Study Start

July 10, 2017

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

July 5, 2018

Record last verified: 2018-06

Locations

CN(1)