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

Sponsor
Xijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04971356
Collaborator
(none)
1,908
1
2
61
31.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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)
  • Drug: Aspirin 100mg for 12-month (immediately after PCI)
  • Drug: Ticagrelor 90mg for 12-month (immediately after PCI)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1908 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Aspirin Plus Ticagrelor for 1 Month Followed by 5 Months Ticagrelor Monotherapy Versus Aspirin Plus Ticagrelor for 12 Months in Acute Coronary Syndrome Patients With Drug-coated Balloon: a Multicentre, Randomized, Non-inferiority Trial
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental arm

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

Drug: Ticagrelor 90mg for 6-month (immediately after PCI)
Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm

Drug: Aspirin 100mg for 6-month (6-month post PCI)
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

Active Comparator: Reference arm

12-month Aspirin plus Ticagrelor

Drug: Aspirin 100mg for 12-month (immediately after PCI)
Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm

Drug: Ticagrelor 90mg for 12-month (immediately after PCI)
Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm

Outcome Measures

Primary Outcome Measures

  1. Net adverse clinical events (NACE) [12 months]

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

Other Outcome Measures

  1. BARC type 3 or 5 bleeding events [1 and 12 months]

    Bleeding events type 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria

  2. BARC type 2 ,3 or 5 bleeding events [1 and 12 months]

    Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria

  3. BARC defined type 2 bleeding events [1 and 12 months]

    Bleeding events type 2 defined by BARC (Bleeding Academic Research Consortium) criteria

  4. Rate of NACE [1 months]

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

  5. Device-oriented Composite Endpoint (DoCE) [1 and 12 months]

    DoCE is a composite clinical endpoint of cardiac cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)

  6. Cardiac death [1 and 12 months]

    Rates of individual components of DoCE

  7. Target vessel myocardial infraction (TV-MI) [1 and 12 months]

    Rates of individual components of DoCE

  8. Clinically individual target lesion revascularization (CI-TLR) [1 and 12 months]

    Rates of individual components of DoCE

  9. Patient-oriented Composite Endpoint (PoCE) [1 and 12 months]

    PoCE defined as all-cause death, any stroke, any MI, any revascularization

  10. All-cause death [1 and 12 months]

    Rates of individual components of PoCE

  11. Any MI [1 and 12 months]

    Rates of individual components of PoCE

  12. Any stroke [1 and 12 months]

    Rates of individual components of PoCE

  13. Any revascularization [1 and 12 months]

    Rates of individual components of PoCE

  14. Target vessel failure (TVF) [1 and 12 months]

    Target vessel failure is defined as cardiovascular death, target vessel myocardial infraction (TV-MI), and clinically-indicated target vessel revascularization

  15. Clinically-indicated target vessel revascularization [1 and 12 months]

    Rates of individual components of TVF

  16. Definite/Probable stent thrombosis rates [1 and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients with an indication for PCI due to acute coronary syndrome

  2. All target lesions can be successful treatment of PCI with drug-coated balloon (DCB)

  3. Patients who are able to complete the follow-up and compliant to the prescribed medication

Exclusion Criteria:
  1. Under the age of 18 or Older than 80 years old

  2. Unable to give informed consent

  3. 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)

  4. Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.

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

  6. Planned elective surgery

  7. Concurrent medical condition with a life expectancy of less than 1 years

  8. Previous intracranial haemorrhage

  9. Need long-term oral anticoagulant therapy

  10. Cardiogenic shock

  11. Previous stent implantation 6 month

  12. In-stent thrombosis

  13. Target lesion located in surgical conduit

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ling Tao Xi'an Shannxi China 710032

Sponsors and Collaborators

  • Xijing Hospital

Investigators

  • Study Chair: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LingTao, Professor in cardiology, Director of the department of Cardiology, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT04971356
Other Study ID Numbers:
  • CAGE-FREE II
First Posted:
Jul 21, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by LingTao, Professor in cardiology, Director of the department of Cardiology, Xijing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022