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

NCT05015699 | Withdrawn

• 1 other identifier: PIONEER IV CHINA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Healing-Targeted Supreme; one month DAPT

Outcome Measures

Primary Outcomes (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)

  12 months post-procedure

Secondary Outcomes (14)

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

  2 and 3 years post-procedure

• Rate of Individual components of patient-oriented composite endpoint;

  1, 2 and 3 years post-procedure

• Rate of Vessel-oriented composite endpoints (VoCE)

  1, 2 and 3 years post-procedure

• Rate of Individual components of vessel-oriented composite endpoint;

  1, 2 and 3 years post-procedure

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

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

Other Outcomes (6)

• The percentage of the struts' neointimal coverage (%) measured by OCT

  1 month post procedure

• Neointimal hyperplasia area/volume measured by OCT

  1 month post procedure

• Mean/Minimal Stent diameter/area/volume

  1 month post procedure

Study Arms (1)

HT Supreme

EXPERIMENTAL

Device: 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

Device: HT Supreme

Interventions

HT Supreme DEVICE

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

HT Supreme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Currently participating in another trial and not yet at its primary endpoint
• Active pathological bleeding;
• History of intracranial haemorrhage.
• 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.

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead
• The Second Affiliated Hospital of Harbin Medical University: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bo Yu, PH.D

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Haibo Jia, PH.D

  The Second Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 20, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: July 1, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04