Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy - Clinical Trial for Coronary Artery Disease | NCT05952206

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Angiolite: Sirolimus-eluting stent

Xience: Sirolimus-eluting stent

1-month DAPT

12-month DAPT (Standard of care)

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring angiolite, dual antiplatelet therapy, percutaneous coronary intervention

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All-comers patients; Age >18 - < 95 years; Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length); Able to provide informed consent and willing to participate in the trial. Exclusion Criteria: Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.; Known severe hepatic impairment Child-Pug stage C; Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period; Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI; Active major bleeding or major surgery within the last 30 days; Known stroke (any type) within the 30 days prior to the randomization; Known pregnancy at time of randomization; Female who is breastfeeding at time of randomization; Women of childbearing potential. Defined: a woman is considered potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Currently participating in another randomized controlled trial and not yet at its primary endpoint; Life expectancy less than one year due to non-cardiovascular comorbidity.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Angiolite and abbreviated DAPT

Xience stent family and abbreviated DAPT

Angiolite and standard of care DAPT

Xience stent family and standard of care DAPT

Arm Description

Acute coronary syndrome patients: Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6 months. No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1M. Only the same P2Y12 inhibitor up to 12M. Chronic coronary syndrome patients: Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.

Acute coronary syndrome patients: Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Only the same P2Y12 inhibitor up to 12M. Chronic coronary syndrome patients: Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.

Acute coronary syndrome patients: Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M. Chronic coronary syndrome: Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.

Outcomes

Primary Outcome Measures

To determine the rate of target lesion failure between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group.

To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) between an abbreviated DAPT regimen and the standard of care DAPT (tested for superiority of the experimental arm).

Secondary Outcome Measures

To determine the rate of adverse ischemic events between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy (tested for non-inferiority).

Rate of target lesion failure between angiolite stent and Xience stent family (Skypoint or Sierra) (tested for non-inferiority) in the standard of care subgroup.

Full Information

NCT ID

NCT05952206

First Posted

May 24, 2023

Last Updated

July 11, 2023

Sponsor

iVascular S.L.U.

1. Study Identification

Unique Protocol Identification Number

NCT05952206

Brief Title

Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy

Acronym

ANGIODAPT

Official Title

Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 2023 (Anticipated)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

iVascular S.L.U.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Factorial 2x2, all-comer, multicentre, single-blinded, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be patient-observer blinded (participant and investigator doing follow-ups) for the stent type and open-label for the antiplatelet regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

angiolite, dual antiplatelet therapy, percutaneous coronary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Model Description

Phase III, prospective, randomized (1:1:1:1), factorial design 2x2, active control, patient-observer blinded and multicentre clinical trial.

Masking

ParticipantOutcomes Assessor

Masking Description

Masking: Patient-observer blinded for the stent type allocation. Open-label for the antiplatelet regimen

Allocation

Randomized

Enrollment

2312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Angiolite and abbreviated DAPT

Arm Type

Experimental

Arm Description

Acute coronary syndrome patients: Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6 months. No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1M. Only the same P2Y12 inhibitor up to 12M. Chronic coronary syndrome patients: Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.

Arm Title

Xience stent family and abbreviated DAPT

Arm Type

Experimental

Arm Description

Acute coronary syndrome patients: Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Only the same P2Y12 inhibitor up to 12M. Chronic coronary syndrome patients: Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M. No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.

Arm Title

Angiolite and standard of care DAPT

Arm Type

Active Comparator

Arm Description

Acute coronary syndrome patients: Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M. Chronic coronary syndrome: Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.

Arm Title

Xience stent family and standard of care DAPT

Arm Type

Active Comparator

Arm Description

Acute coronary syndrome patients: Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M. Chronic coronary syndrome: Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M. No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.

Intervention Type

Device

Intervention Name(s)

Angiolite: Sirolimus-eluting stent

Other Intervention Name(s)

iVascular angiolite

Intervention Description

The angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release.

Intervention Type

Device

Intervention Name(s)

Xience: Sirolimus-eluting stent

Other Intervention Name(s)

Xience stent family

Intervention Description

The Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™

Intervention Type

Drug

Intervention Name(s)

1-month DAPT

Intervention Description

DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC

Intervention Type

Drug

Intervention Name(s)

12-month DAPT (Standard of care)

Intervention Description

DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC

Primary Outcome Measure Information:

Title

To determine the rate of target lesion failure between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group.

Time Frame

1 year

Title

To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) between an abbreviated DAPT regimen and the standard of care DAPT (tested for superiority of the experimental arm).

Time Frame

1 year

Secondary Outcome Measure Information:

Title

To determine the rate of adverse ischemic events between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy (tested for non-inferiority).

Time Frame

1 year

Title

Rate of target lesion failure between angiolite stent and Xience stent family (Skypoint or Sierra) (tested for non-inferiority) in the standard of care subgroup.

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

To determine the rate of Patient-Oriented Composite endpoint

Time Frame

1-2-3-4-5 years

Title

To determine the rate of individual components of All cause, cardiovascular, and cardiac death

Time Frame

1-2-3-4-5 years

Title

To determine the rate of recurrent myocardial infarction

Time Frame

1-2-3-4-5 years

Title

To determine the rate of target lesion revascularization

Time Frame

1-2-3-4-5 years

Title

To determine the rate of target vessel revascularization

Time Frame

1-2-3-4-5 years

Title

To determine the rate of stent thrombosis

Time Frame

1-2-3-4-5 years

Title

To determine the rate of clinical device success

Time Frame

Immediatly after the procedure

Title

To determine the rate of clinical procedural success

Time Frame

Immediatly after the procedure

Title

To determine the rate of bleeding events

Time Frame

1-2-3-4-5 years

Title

To determine the rate of net adverse clinical endpoints (NACE)

Time Frame

1-2-3-4-5 years

Title

To determine the rate of major adverse cardiac and cerebral events (MACCE)

Time Frame

1-2-3-4-5 years

Title

To determine the rate of transfusion rates

Time Frame

1-2-3-4-5 years

Title

To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study

Time Frame

1 year

Title

To determine the rate of adverse ischemic events at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: All-comers patients; Age >18 - < 95 years; Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length); Able to provide informed consent and willing to participate in the trial. Exclusion Criteria: Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.; Known severe hepatic impairment Child-Pug stage C; Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period; Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI; Active major bleeding or major surgery within the last 30 days; Known stroke (any type) within the 30 days prior to the randomization; Known pregnancy at time of randomization; Female who is breastfeeding at time of randomization; Women of childbearing potential. Defined: a woman is considered potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Currently participating in another randomized controlled trial and not yet at its primary endpoint; Life expectancy less than one year due to non-cardiovascular comorbidity.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sara Pich, PhD

Phone

+34 936 724 711

Email

spich@ivascular.global

First Name & Middle Initial & Last Name or Official Title & Degree

Lucía Gayoso

Phone

+34645093750

Email

LGayoso@bcccbarcelona.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manel Sabaté

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy (ANGIODAPT)

Coronary Artery Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial