CLEAR-PATH trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Utrecht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

22 Jul 2024 → ongoing

Decision date (initial)

2024-07-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMW

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess whether and to what extent DAPT is superior to SAPT, in reducing the combined endpoint of all-cause death, MACE and MALE within one-year follow-up in PAD patients who underwent EVR.

Secondary objectives 8

1. To assess whether and to what extent DAPT is superior to SAPT, in reducing the combined endpoint of all-cause death, MACE and MALE within 30 days follow-up in PAD patients who underwent EVR.
2. To assess to what extent DAPT as compared to SAPT reduces the MALE within 30 days and one year after the EVR.
3. To assess to what extent DAPT as compared to SAPT reduces the MACE within 30 days and one year after the EVR.
4. To assess to what extent DAPT as compared to SAPT reduces cardiovascular death in PAD patients who underwent endovascular intervention within 30 days and one year.
5. To assess to what extent DAPT as compared to SAPT increases the occurrence of major bleeding within 30-days follow-up in PAD patients who underwent an EVR for PAD by using the TIMI classification.
6. To assess to what extent DAPT as compared to SAPT increases the occurrence of any and/or major bleedings within one-year follow-up and after total follow-up in PAD patients who underwent EVR for PAD by using the TIMI (only any bleeding), BARC criteria and ISTH classification.
7. To assess to what extent DAPT as compared to SAPT increases the occurrence of major bleedings following the TIMI classification within one-year follow-up in PAD patients who underwent EVR for PAD.
8. To assess to what extent DAPT as compared to SAPT increases the quality of life and decreases costs.

Conditions and MedDRA coding

(Chronic) Peripheral (occlusive) arterial disease (PAD)

Regulatory references

Scientific advice from competent authorities

Central Committee On Research Involving Human Subjects

Plan to share IPD

No

IPD plan description

n/a

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Lesions of the iliac, femoropopliteal, and/or below-the-knee (BTK) arteries;
2. At least one TASC lesion;
3. Rutherford (1-6) classes with an indication for an endovascular intervention
4. Proficient understanding of the consequences of enrolment by the patient
5. Written informed consent by the patient;
6. Age ≥ 45 years
7. And eligibility of lesions for; 1. Percutaneous transluminal angioplasty (PTA) or recanalization with or without additional stenting based on prevailing guidelines, or; 2. Hybrid procedure with an endarterectomy of the common femoral artery and additional iliac, femoral or tibial PTA, or; 3. A reintervention within 2 months due to a phased treatment.

Exclusion criteria 12

1. Acute (limb) ischemia
2. Reported intolerance or hypersensitivity to the study medications
3. Use of anticoagulant therapy (DOACs or coumarin)
4. Use of non-steroidal anti-inflammatory drugs >2 weeks which cannot be discontinued
5. Patients incompetent of understanding the consequences of enrolment in the trial
6. Patients with a reintervention due to restenosis/reocclusion within 2 months
7. Patients with a hybrid procedure other than endarterectomy of the common femoral artery such as femoral bypass
8. Patients with coagulopathy
9. Patients with a peptic ulcer confirmed by an esophagogastroduodenoscopy in their medical history
10. Patients who are pregnant/contemplating pregnancy/nursing.
11. Patients requiring dialysis
12. Patients with liver failure and at least one of the following criteria; 1. elevated INR value, or; 2. portal hypertension, or; 3. thrombocytopenia <50x10^9/L, or; 4. INR, portal tension, or platelet count are unknown.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is all-cause death and the occurence of cardiovascular adverse events after 1 year: (indication for) re-intervention due to any restenosis or re-occlusion or due to acute limb ischemia, the occurence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death.

Secondary endpoints 1

1. The secondary endpoint is the occurence of all and major bleeding (following the TIMI bleeding classification and BARC criteria), major adverse cardiovascular events (MACE), and major adverse limb events (MALE). CYP2C19 polymorphisms will be determined to examine if non-responsiveness to clopidogrel predicts outcome.

Investigational products

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

Test 1

Comparator 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Utrecht

Sponsor organisation

Universitair Medisch Centrum Utrecht

Address

Heidelberglaan 100

City

Utrecht

Postcode

3584 CX

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

Wetenschapsbureau

Public contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

Wetenschapsbureau

Locations

1 EU/EEA country · 19 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 12 files

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

Application history

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