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Coronary Artery DiseaseNCT05015699

A Study to Evaluate the Impact of 11-month Ticagrelor Monotherapy Following One-month DAPT After PCI

A study testing HT Supreme in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

PIONEER IV CHINA is sought to investigate the safety and efficacy of 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system at 12 months follow-up. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
HT Supreme
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2021to Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patient ≥18 years of age;
  • Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
  • Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation;
  • The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length);
  • Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.

Who cannot join

  • under 18 years of age;
  • Unable to sign written informed consent
  • Patient is a woman who is pregnant or nursing
  • Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
  • Planned major elective surgery requiring discontinuation of DAPT within 12 months of procedure;
  • Concurrent medical condition with a life expectancy of less than 3 years;
Show all 13Show fewer
  • Currently participating in another trial and not yet at its primary endpoint
  • Active pathological bleeding;
  • History of intracranial haemorrhage.
  • OCT exclusion criteria
  • Left main lesion
  • Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
  • Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.

About this study

Official title: A Prospective, Multi-center, Single-group Target Value Post-marketing Clinical Study to Evaluate the Safety and Effectiveness of the HT Supreme Drug-eluting Stent System in the Treatment of "Real-world" Patients With Coronary Heart Disease

PIONEER IV CHINA is sought to investigate the safety and efficacy of 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system at 12 months follow-up.

Read the detailed description

This study is a prospective, multi-center, single-arm objective performance criteria clinical trial in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent and treated with 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) in approximately 285 patients (including 80 coronary heart disease cases entering the OCT subgroup). All patients will be (at minimum) contacted via visit at 30 days (±7 days) and at 12 months (±30 days), and by phone contact at 6 months (±14 days), 24 months (±30 days) and 36 months (±45 days) post index procedure to assess clinical status and adverse events. The Primary Endpoint for this trial is Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.

Being tested
HT Supreme
Keywords
Healing-Targeted Supreme, one month DAPT
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HT SupremeDevice

    HT Supreme ( R\&D by Sinomed, Tianjin, China)

Study groups in NCT05015699
Study groupRoleWhat they receive
HT SupremeExperimentalDevice: HT Supreme ( R\&D by Sinomed, Tianjin, China) Drug: 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system interventions
Receives: Device: HT Supreme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.

    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (peri-procedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)

    Measured: 12 months post-procedure

Secondary outcomes (14)

  1. Rate of Patient oriented composite endpoint (PoCE) at 2 and 3 years;

    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)

    Measured: 2 and 3 years post-procedure

  2. Rate of Individual components of patient-oriented composite endpoint;

    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)

    Measured: 1, 2 and 3 years post-procedure

  3. Rate of Vessel-oriented composite endpoints (VoCE)

    VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2)

    Measured: 1, 2 and 3 years post-procedure

  4. Rate of Individual components of vessel-oriented composite endpoint;

    VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2)

    Measured: 1, 2 and 3 years post-procedure

  5. Rate of Device-oriented composite endpoint (DoCE) at all timepoints;

    VoCE is a composite clinical endpoint of: Cardiovascular Death；Target-vessel related MI；Clinically and physiologically-oriented Target lesion revascularization

    Measured: 30days, 6months, annually up to 3 years post procedure

  6. Rate of Individual components of device-oriented composite endpoint;

    VoCE is a composite clinical endpoint of: Cardiovascular Death；Target-vessel related MI；Clinically and physiologically-oriented Target lesion revascularization

    Measured: 30days, 6months, annually up to 3 years post procedure

  7. Rate of Pre-procedural myocardioal infarction according to 4th universal definition;

    Fourth Universal Definition of Myocardial Infarction (2018)

    Measured: 30days, 6months, annually up to 3 years post procedure

  8. Device Success Rate

    according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC))

    Measured: intra-operative

  9. Rate of Stent thrombosis

    Stent thrombosis is consist of Definite stent thrombosis; Probable stent thrombosis; Definite or probable stent thrombosis

    Measured: 30days, 6months, annually up to 3 years post procedure

  10. Rate of Target-vessel failure composite endpoint

    TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization

    Measured: 30days, 6months, annually up to 3 years post procedure

  11. Rate of Individual components of Target-vessel failure composite endpoint

    TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization

    Measured: 30days, 6months, annually up to 3 years post procedure

  12. Rate of Bleeding according to BARC (2, 3 and 5) classification

    Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk

    Measured: 30days, 6months, annually up to 3 years post procedure

  13. Rate of Net adverse clinical and cerebral events

    NACCE is a composite clinical endpoint of: any cause, myocardial infarction (MI), cerebral vascular accident, and major bleeding (according to the modified REPLACE-2 and GUSTO criteria)

    Measured: 30days, 6months, annually up to 3 years post procedure

  14. Cost-Effectiveness

    Cost of procedure will be collected in the eCRF(e.g. diagnostic tests, procedural materials, time of the procedure, re-angiography, repeat revascularization, etc. will be quantified).

    Measured: hospitalization, 1 year post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionJul 2025 (estimated)

Why it stopped: Withdrawn of the research project based on the company's decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05015699
Sponsor's protocol ID
PIONEER IV CHINA
Status last verified
Apr 2024
First submitted
1 Aug 2021
Last updated
25 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing HT Supreme in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure. (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05015699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

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