1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon

NCT04971356 | Active Not Recruiting DMC

• 1 other identifier: CAGE-FREE II
• Study Type: interventional
• Target: 1,948
• Locations: 1 country
• Sites: 1

Brief Summary

Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated to the balloon. Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Bleeding after PCI remains a substantial clinical problem. Bleeding post-PCI increases the risk of adverse outcomes such as death, non-fatal myocardial infarction, and prolongs hospital stay. Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 5.7-fold. The antiplatelet medications are the major cause of bleeding events post-PCI. Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome. Compared with the DES, because of the absence of metal inside the coronary artery, the use of DCB might theoretically allow shorter duration antiplatelet therapy. However, the optimal course of DAPT for the DCB treated patients remains controversial. In 2013, the consensus from the German group suggested that for the acute coronary syndrome, DAPT should be used for 12 months. The consensus of DAPT developed by the European Society of Cardiology (ESC) in 2017 stated that "in patients treated with DCB, dedicated clinical trials investigating the optimal duration of DAPT are lacking." So far, there are no randomized data showing the optimal DAPT duration for the DCB treated patients. In the current study, we use Aspirin + Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month, afterward, Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm, to compare with the Reference arm, which is Aspirin + Ticagrelor for 12-month in a non-inferiority statistical assumption, aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment.

Conditions

Antiplatelet Drug; Acute Coronary Syndrome; Angioplasty, Balloon

Keywords

Ticagrelor Monotherapy; Acute coronary syndrome; Drug-coated balloons

Outcome Measures

Primary Outcomes (1)

• Net adverse clinical events (NACE)

  NACE is a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events

  12 months

Secondary Outcomes (17)

• Any ischemic or bleeding event

  1, 6 and 12 months

• BARC type 3 or 5 bleeding events

  1, 6 and 12 months

• BARC type 2 ,3 or 5 bleeding events

  1, 6 and 12 months

• BARC defined type 2 bleeding events

  1, 6 and 12 months

• Rate of NACE

  1 and 6 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months

Drug: Aspirin 100mg for 1-month (immediately after PCI); Drug: Ticagrelor 90mg for 6-month (immediately after PCI); Drug: Aspirin 100mg for 6-month (6-month post PCI)

Reference arm

ACTIVE COMPARATOR

12-month Aspirin plus Ticagrelor

Drug: Aspirin 100mg for 12-month (immediately after PCI); Drug: Ticagrelor 90mg for 12-month (immediately after PCI)

Interventions

Aspirin 100mg for 1-month (immediately after PCI) DRUG

Aspirin for 1-month immediately after PCI to be a part of medication treatment in the Experimental arm

Experimental arm

Ticagrelor 90mg for 6-month (immediately after PCI) DRUG

Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm

Experimental arm

Aspirin 100mg for 6-month (6-month post PCI) DRUG

Aspirin for 6-month at 6 months post-PCI (after the discontinuation of the 6-month Ticagrelor treatment) to be a part of medication treatment in the Experimental arm

Experimental arm

Aspirin 100mg for 12-month (immediately after PCI) DRUG

Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm

Reference arm

Ticagrelor 90mg for 12-month (immediately after PCI) DRUG

Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm

Reference arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an indication for PCI due to acute coronary syndrome
• All target lesions can be successful treatment of PCI with drug-coated balloon (DCB)
• Patients who are able to complete the follow-up and compliant to the prescribed medication

You may not qualify if:

• Under the age of 18 or Older than 80 years old
• Unable to give informed consent
• Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
• Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
• Currently participating in another trial and not yet at its primary endpoint
• Planned elective surgery
• Concurrent medical condition with a life expectancy of less than 1 years
• Previous intracranial haemorrhage
• Need long-term oral anticoagulant therapy
• Cardiogenic shock
• Previous stent implantation 6 month
• In-stent thrombosis
• Target lesion located in surgical conduit

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ling Tao

Xi'an, Shannxi, 710032, China

Location

Related Publications (2)

• Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945.

  PMID: 40164448 DERIVED

• Gao C, Zhu B, Liu J, Jiang Z, Hu T, Wang Q, Liu Y, Yuan M, Li F, Zhang R, Xia J, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Study Group. Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design. BMC Cardiovasc Disord. 2024 Jan 20;24(1):62. doi: 10.1186/s12872-024-03709-1.

  PMID: 38245724 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Aspirin; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Ling Tao, MD,PHD

  Xijing Hospital

  STUDY CHAIR

• Patrick Serruys, MD,PHD

  National University of Ireland, Galway

  STUDY CHAIR

• Yoshinobu Onuma, MD,PHD

  National University of Ireland, Galway

  STUDY CHAIR

• Chao Gao, MD,PHD

  Xijing Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in cardiology, Director of the department of Cardiology

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 21, 2021
• Study Start: November 1, 2021
• Primary Completion: March 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)