Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI (DEBATE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Wellbeing Services County Of North Karelia Siun Sote

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

11 Jan 2024 → ongoing

Decision date (initial)

2024-01-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

B Braun Melsungen, Germany · Finnish Cardiovascular Foundation

External identifiers

EU CT number

2023-504340-34-01

ClinicalTrials.gov

NCT04814212

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The purpose of this study is to compare percutaneous coronary intervention using drug-coated balloon (DCB) with drug-eluting stents (DES) in stable coronary artery disease (CAD) or in acute coronary syndromes (ACS) in patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter dual-antiplatelet (DAPT) treatment is non-inferior to the treatment using DES and longer DAPT duration in patients with high bleeding risk.

Secondary objectives 1

1. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

Conditions and MedDRA coding

Coronary artery disease

Study design 1 period

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Age ≥ 18 years, informed written consent, at least one major or two minor bleeding risk criteria of Academic Research Consortium (ARC). Either of the following: Stabile angina or dyspnea and a coronary narrowing causing myocardial ischemia detected in the angiogram. In stable patients prior PCI, the evidence of ischemia is needed acquired either by perfusion imaging or by pressure wire measurement (FFR) during coronary angiography unless the coronary stenosis is > 90% in diameter. ACS (UAP or NSTEMI): symptoms of heart ischemia≥ 20 minutes and ≥ 0,5mm ST-depression or transient ST-elevation or T-wave inversion at least in two adjacent leads and/or a high sensitivity troponin (hs-tnt) rise at least one unit above the 99. percentil or at least 50% rise in hs-tnt between two samples taken 1-3 hours apart. At least one of the following: ≥1 de novo lesions in native coronary arteries or bypass vein grafts. Reference diameter of the vessel is 2.0-5.0mm. Lesion length ≤ 40mm. Lesion or lesions are suitable for PCI.

Exclusion criteria 1

1. Inability to give written consent STEMI. Reference diameter of the vessel is <2.0mm or >5.0 mm. Bifurcation lesion requiring the stenting of either of the branches after predilatation. (TIMI<3 or significant recoil >30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation). Dissection affecting the flow (TIMI<3) or significant recoil (>30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation. In-stent restenosis. Chronic total occlusion. Life expectancy < 12 months. Cardiogenic shock at the arrival to the coronary angiography. Uncertainty about neurological recovery e.g. after resuscitation. Need for bypass surgery by heart team decision.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the composite of MACE and BARC (Bleeding academic research consortium) type 2-5 bleeding episodes at 12 months. Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)

Secondary endpoints 17

1. The composite of MACE and BARC2-5 bleedings (24 and 36 months)
2. MACE 12, 24 and 26 months
3. BARC2-5 bleedings 12, 24 and 26 months
4. BARC3-5 bleedings 12, 24 and 26 months
5. Total mortality 12, 24 and 26 months
6. Cardiovascular mortality 12, 24 and 26 months
7. Myocardial infarction 12, 24 and 26 months
8. TLR 12, 24 and 26 months
9. Target-vessel failure (TVF) 12, 24 and 26 months
10. Target-lesion failure (TLF) 12, 24 and 26 months
11. The composite of TLR and BARC2-5 bleedings 12, 24 and 26 months
12. The composite of TVF and BARC2-5 bleedings 12, 24 and 26 months
13. The composite of TLF and BARC2-5 bleedings 12, 24 and 26 months
14. The composite of TLR and BARC3-5 bleedings 12, 24 and 26 months
15. Acute vessel closure as defined by the consensus criteria for definite/probable stent thrombosis
16. Hospitalization for urgent revascularization
17. Stroke (ischemic or hemorrhagic) or TIA 12, 24 and 26 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Wellbeing Services County Of North Karelia Siun Sote

Sponsor organisation

Wellbeing Services County Of North Karelia Siun Sote

Address

Tikkamaentie 16

City

Joensuu

Postcode

80210

Country

Finland

Scientific contact point

Organisation

Wellbeing Services County Of North Karelia Siun Sote

Contact name

Tuomas T Rissanen

Public contact point

Organisation

Wellbeing Services County Of North Karelia Siun Sote

Contact name

Tuomas T Rissanen

Third parties 1

Locations

3 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications