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

NCT ID: NCT05015699

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2025-07-31

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HT Supreme

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

Group Type: EXPERIMENTAL

HT Supreme

Intervention Type: DEVICE

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

Interventions

HT Supreme

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female patient ≥18 years of age;

2. Patient has chronic stable angina, acute coronary syndromes or silent ischemia;

3. 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;

4. 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);

5. 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.

Exclusion Criteria

1. under 18 years of age;

2. Unable to sign written informed consent

3. Patient is a woman who is pregnant or nursing

4. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;

5. Planned major elective surgery requiring discontinuation of DAPT within 12 months of procedure;

6. Concurrent medical condition with a life expectancy of less than 3 years;

7. Currently participating in another trial and not yet at its primary endpoint

8. Active pathological bleeding;

9. History of intracranial haemorrhage.

1. Left main lesion

2. 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

3. Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

Sino Medical Sciences Technology Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bo Yu, PH.D

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Haibo Jia, PH.D

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Harbin Medical University

Other Identifiers

PIONEER IV CHINA

Identifier Type: -

Identifier Source: org_study_id