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Status unknownNCT04307511TIGER-diabetesUpdated Apr 22, 2024

A sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients

A Phase 4 interventional study of Ticagrelor and Aspirin in Acute Coronary Syndrome Patients With Diabetes After PCI, sponsored by Shanghai Tong Ren Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Shanghai Tong Ren Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

In this study, the investigates try to confirm the hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in acute coronary syndrome patients with diabetes. Totally 40 ACS patients with diabetes will be divided into 2 groups randomly after PCI for one month. Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group2 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 at 1 and 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.

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Conditions studied

  • Acute Coronary Syndrome Patients With Diabetes After PCI
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In context

Lead sponsor

Shanghai Tong Ren Hospital is the lead sponsor of 17 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject must be at least 18 years of age and less than 90 years old
  2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome with diabetes mellitus.
  3. Subject understand the study requirements and the treatment procedures and
  4. provided informed consent before the procedure

Exclusion criteria

Exclusion Criteria:

  1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  2. Active bleeding
  3. Known hypersensitivity or contraindication to study medications
  4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  5. 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).
  6. Subjects with Cerebral hemorrhage history
  7. Subjects with stroke history in half a year
  8. subjects with active malignant tumor
  9. subjects with whom oral anticoagulants are needed
  10. Other conditions which the investigators think not applicable to the study.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    low dose DAPT therapy

    treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT(ticagrelor 90mg plus aspirin 100 mg )treatment

    Drug: Ticagrelor · Drug: Aspirin

  • Active comparator
    standard dose DAPT therapy

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

    Drug: Ticagrelor · Drug: Aspirin

Interventions

  • DrugTicagrelor

    60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy

  • DrugAspirin

    Aspirin

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What researchers measure

Primary outcomes

  1. changes of PRI detected by VASP

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

    Time frame: changes of PRI from baseline (1 months after index PCI) to 2 months after index PCI

  2. changes of Maximum Amplitude (MA) detected by TEG

    Maximum Amplitude (MA) detected by TEG(Thromboelastography)

    Time frame: changes of MA from baseline (1 months after index PCI) to 2 months after index PCI

07

Study locations

1 of 1 sites recruiting
  • shanghai Tongren hospital
    Shanghai, 200336, China
    • Lei Hou, Doctor · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04307511
Lead sponsor
Shanghai Tong Ren Hospital
Responsible party
Hou Lei (Clinical Professor, Shanghai Tong Ren Hospital) — Principal investigator
First posted
Mar 13, 2020
Start date
Apr 20, 2020
Primary completion
Apr 30, 2024 (estimated)
Completion
May 31, 2024 (estimated)
Last update
Apr 22, 2024

Study contacts

Lei Hou, Doctor
Contact
Dr_houlei@163.com
13564868096

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ticagrelor

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Shanghai Tong Ren Hospital

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