Coronary Artery DiseasePhase 2SYNIVUS-DAPTNCT03606642

SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Anti-Platelet Therapy

A Phase 2 study testing Dual Antiplatelet (DAPT) Therapy and The Synergy® stent in people with Coronary Artery Disease and Atherosclerosis, run by HonorHealth Research Institute at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to see if one month of dual antiplatelet therapy (DAPT) combined with the placement of the Synergy® Stent with IVUS (intravascular ultrasound) is safe for patients who are at high risk of bleeding (HBR). Read more about this study

Who is it for?: Ages 75 years and older
Conditions the study is for: Coronary Artery Disease, Atherosclerosis, Stent Placement
What is being tested?: Dual Antiplatelet (DAPT) Therapy and The Synergy® stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesUnited States
Study dates: 19 Nov 2018to 8 Aug 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:
Greater than or equal to 75 years of age and, in the opinion of the investigator, the risk of bleeding associated with >1 months of DAPT outweighs the benefit,
need for chronic or lifelong anticoagulation therapy
history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
history of stroke (ischemic or hemorrhagic),
renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),

Show all 19Show fewer

platelet count ≥20,000/μLto ≤100,000/μL (microliters)
In the opinion of investigator, patient is at significant risk of falling
Patient abuses drugs or alcohol
Hemoglobin ≤11.0 u/dl 2. Subject must be 18 years of age 3. Subject must be able to take study required dual antiplatelet therapy (1 month of P2Y12 inhibitor and aspirin, 13 months of antiplatelet monotherapy) 4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 1-month milestone if eligible per protocol 5. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific procedures are performed
Angiographic Inclusion Criteria:
Subject must have had implantation of at least one Synergy Stent and the use of Boston Scientific IVUS for guided stent implantation
All implanted stents must be post dilated and must meet the following IVUS success criteria:
treated lesions in which the stent cross sectional area exceeds the distal reference cross sectional area
if the stent cross sectional area is less than the distal reference cross sectional area additional post-dilatation must be performed, followed by IVUS
above IVUS criteria must be met after the 2nd post dilatation NOTE: if the IVUS criteria is not met after the 2 post dilatation the patient is excluded
Stent procedure performed by an approved investigator
Vessel diameter ≥ 2.25 mm and ≤4.0 mm and lesion length ≤34mm
Pre-dilatation is up to the discretion of the investigator

Who cannot join

Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
Subject with treatment with another coronary stent, other than SYNERGY Stent during the index procedure
Subject with a planned staged procedure >7 days following the index procedure. (Note: Planned staged procedures are allowed if performed within 7 days of the index procedure and only when SYNERGY stents are used for both the index and staged procedure). Discontinuation of DAPT should occur 1 month after the last PCI procedure is completed.
A staged procedure cannot in a 3rd epicardial vessel if 2 epicardial vessels were treated during the index procedure
Subject has a known allergy to: contrast (that cannot be adequately pre-medicated), the SYNERGY Stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)

Show all 33Show fewer

Subject previously treated at any time with intravascular brachytherapy
Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)
Subject intends to participate in an investigational drug or device clinical trial within 12 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)
Subject is judged inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use
if at the 30 day visit, the patient has had a peri-procedural NSTEMI with an enzyme elevation >5% of the upper 99th percentile of either creatine kinase-myocardial band (CK-MB) or Troponin, the patient should not be taken off DAPT
Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure
Subject is a woman who is pregnant or nursing
Subject with a current medical condition with a life expectancy of less than 12 months
Subject with implantation of a drug-eluting stent other than SYNERGY Stent within 11 months prior to index procedure
Have been previously consented for this trial and screen failed
Any other clinically significant comorbidities, which in the judgement of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
Angiographic Exclusion Criteria:
Target lesion(s) is located within a saphenous vein graft or an arterial graft
TIMI (Thrombolysis In Myocardial Infarction) flow 0 (total occlusion)
Target lesion(s) is located in the left main
Potential Target lesion(s) that involve a complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
Patients requiring a treatment of more than two native epicardial vessels
More than three lesions in two epicardial vessels unless they can be covered in one stent
In-stent restenosis of target lesion
Treatment of non-target lesions or lesions not treated with a Synergy stent
Subject who did not receive Boston Scientific IVUS guided stent implantation and assessment
Any target lesion that has not been post dilated and has not had post dilatation IVUS
Patients who do not meet the following IVUS success criteria:
target lesion(s) in which the stent cross sectional area is less than the distal reference cross sectional area and additional post-dilatation should be performed, followed by repeat IVUS.
NOTE: if the IVUS criteria is not met after the 2nd post dilatation, the patient is excluded

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Massachusetts General Hospital, Corrigan Minehan Heart Center
Boston, Massachusetts, 02114
Northwell Hospital Systems
New York, New York, 10075
HonorHealth Research Institute
Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month

Read the detailed description

DAPT or Dual Antiplatelet Therapy is a combination of two medications given after a percutaneous coronary intervention (PCI) with a drug eluting stent. DAPT is used to help make the platelets in your blood slick so they don't clump or stick together. If the platelets stick together and form a blood clot in the stent it is called a stent thrombosis and will cause an immediate heart attack or MI.

The medications used for DAPT are low dose Aspirin (81mg) and one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) . The standard length of time to take DAPT after a stent placement is 6 months to 1 year. Dapt is associated with an increased risk of bleeding. Because you are considered to be at a high risk for bleeding due to one or a combination of reasons this study is trying to determine if a shorter use of DAPT in combination with the Synergy® stent and an imaging tool called IVUS used during your PCI procedure is safe and effective to reduce the potential for serious bleeding events and early stent thrombosis.

The Synergy® stent was chosen because of its enhanced method of healing and reduced inflammation of the artery after placement. Because of this the Synergy stent may be a better choice for patients who are at high risk for bleeding and could benefit from a shortened period of DAPT.

Intravascular ultrasound or IVUS provides a visual image of the inside of the coronary artery. It is used in patients undergoing PCI or stent placement for a few reasons; prior to placing the stent it is used to measure the artery's width to select the proper size diameter of a stent, also the length of the blockage to select the appropriate length of the stent and to visualize the amount of narrowing or blockage. After the stent is placed IVUS is used to make sure the stent itself is fully expanded and sits up against the wall of the artery. This is called apposition. If stents are not fully expanded and sit up against the wall of the artery early reblockage may occur. In short the IVUS aids in the ideal placement of the stent.

By using the combination of the Synergy® Stent with the IVUS the expectation is to safely decrease the length of time you take DAPT from 6-12 months to 1 month. With the benefit of decreasing the risk of bleeding events.

Conditions: Coronary Artery Disease, Atherosclerosis, Stent Placement
Being tested: Dual Antiplatelet (DAPT) Therapy, The Synergy® stent
Keywords: Cardiovascular disease, peripheral vascular disease (PVD), Ischemia
Medical subject headings: Coronary Artery Disease, Atherosclerosis, Cardiovascular Diseases, Peripheral Vascular Diseases, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dual Antiplatelet (DAPT) TherapyDrug
Also called Ticagrelor (Brilinta), Clopidogrel (Plavix), Prasugrel (Effient) with Aspirin
DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stentDevice
IVUS guided stent

Study groups in NCT03606642
Study group	Role	What they receive
PCI with 30 day DAPT Therapy	Experimental	Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose [if applicable] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS) Receives: Drug: Dual Antiplatelet (DAPT) Therapy; Device: The Synergy® stent

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Cardiac Death
Rate of cardiac death from 1 to 13 months post-index procedure in the "as treated" (eligible for 30 day DAPT cessation) population.
Measured: 1 to 13 months
Rate of Myocardial Infarction
Rate of myocardial infarction (SCAI definition) from 1 to 13 months post-index procedure in the overall enrolled "intent-to-treat" patient population
Measured: 1 to 13 months

Secondary outcomes (6)

Number of Participants With Definite/Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition
Rate of Academic Research Consortium (ARC) definite/probable stent thrombosis (ST) involving SYNERGY Stent® from 1 to 13 months post-index procedure
Measured: 1 to 13 months
Number of Participants With Major Bleeding
Rate of major bleeding (GUSTO severe/life threatening + moderate)
Measured: 1 to 13 months
Number of Participants With Ischemia-driven (ID) Target Vessel Revascularization,
Angina Assessment
Measured: 1 to 13 months
Number of Participants With Target Vessel Failure
Angina Assessment
Measured: 1 to 13 months
Number of Participants With All-Cause Death
Angina Assessment
Measured: 1 to 13 months
Number of Participants With All-Cause MI (Myocardial Infarction)
Angina Assessment
Measured: 1 to 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 20188 Aug 2022

First posted31 Jul 2018
Study start19 Nov 2018
Primary completion31 Dec 2021
Study completion8 Aug 2022

Why it stopped: The DSMC March 16, 2022 reviewed of Interim Analysis and recommendation due to no glaring outcomes found to date.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: DAPT or Dual Antiplatelet Therapy is a combination of two medications given after a percutaneous coronary intervention (PCI) with a drug eluting stent. The medications used for DAPT are low dose Aspirin (81mg) and one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient). Because the patients are considered to be at a high risk for bleeding due to one or a combination of reasons this study is trying to determine if a shorter use of DAPT in combination with the Synergy® stent and an imaging tool called IVUS used during your PCI procedure is safe and effective to reduce the potential for serious bleeding events and early stent thrombosis. The Synergy® stent was chosen because of its enhanced method of healing and reduced inflammation of the artery after placement. The Synergy stent may be a better choice for patients who are at high risk for bleeding and could benefit from a shortened period of DAPT.
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03606642
Sponsor's protocol ID: SYNIVUS-DAPT
Acronym: SYNIVUS-DAPT
Status last verified: Dec 2024
First submitted: 23 Jul 2018
Last updated: 27 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month
ClinicalTrials.gov ID: NCT03606642
Acronym / sponsor ID: SYNIVUS-DAPT / SYNIVUS-DAPT
Conditions: Coronary Artery Disease, Atherosclerosis, Stent Placement
Keywords: Cardiovascular disease, peripheral vascular disease (PVD), Ischemia
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The DSMC March 16, 2022 reviewed of Interim Analysis and recommendation due to no glaring outcomes found to date.
Enrolment: 50 participants (actual)
Lead sponsor: HonorHealth Research InstituteUniversity, hospital or other
Collaborators: Boston Scientific Corporation
Study start: 19 Nov 2018 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 8 Aug 2022 (actual)
First posted: 31 Jul 2018 (actual)
Results: Posted 27 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: DAPT or Dual Antiplatelet Therapy is a combination of two medications given after a percutaneous coronary intervention (PCI) with a drug eluting stent. The medications used for DAPT are low dose Aspirin (81mg) and one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient). Because the patients are considered to be at a high risk for bleeding due to one or a combination of reasons this study is trying to determine if a shorter use of DAPT in combination with the Synergy® stent and an imaging tool called IVUS used during your PCI procedure is safe and effective to reduce the potential for serious bleeding events and early stent thrombosis. The Synergy® stent was chosen because of its enhanced method of healing and reduced inflammation of the artery after placement. The Synergy stent may be a better choice for patients who are at high risk for bleeding and could benefit from a shortened period of DAPT.

Arm	Type	Receives
PCI with 30 day DAPT Therapy	Experimental	Drug: Dual Antiplatelet (DAPT) Therapy, Device: The Synergy® stentSingle group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose [if applicable] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (19 listed)

Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:
Greater than or equal to 75 years of age and, in the opinion of the investigator, the risk of bleeding associated with >1 months of DAPT outweighs the benefit,
need for chronic or lifelong anticoagulation therapy
history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
history of stroke (ischemic or hemorrhagic),

Key exclusion criteria (33 listed)

Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
Subject with treatment with another coronary stent, other than SYNERGY Stent during the index procedure
Subject with a planned staged procedure >7 days following the index procedure. (Note: Planned staged procedures are allowed if performed within 7 days of the index procedure and only when SYNERGY stents are used for both the index and staged procedure). Discontinuation of DAPT should occur 1 month after the last PCI procedure is completed.
A staged procedure cannot in a 3rd epicardial vessel if 2 epicardial vessels were treated during the index procedure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dual Antiplatelet (DAPT) TherapyAlso: Ticagrelor (Brilinta), Clopidogrel (Plavix), Prasugrel (Effient) with AspirinDAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin. Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg. P2Y12 Inhibitor Loading Dose (investigator preference): Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1. P2Y12 Inhibitor Maintenance Dose (investigator preference): Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.	Drug	PCI with 30 day DAPT Therapy
The Synergy® stentIVUS guided stent	Device	PCI with 30 day DAPT Therapy

Primary outcome

Number of Participants With Cardiac Death
Time frame: 1 to 13 months
Rate of cardiac death from 1 to 13 months post-index procedure in the "as treated" (eligible for 30 day DAPT cessation) population.
Rate of Myocardial Infarction
Time frame: 1 to 13 months
Rate of myocardial infarction (SCAI definition) from 1 to 13 months post-index procedure in the overall enrolled "intent-to-treat" patient population

6 secondary outcomes

Number of Participants With Definite/Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition
Time frame: 1 to 13 months
Number of Participants With Major Bleeding
Time frame: 1 to 13 months
Number of Participants With Ischemia-driven (ID) Target Vessel Revascularization,
Time frame: 1 to 13 months
Number of Participants With Target Vessel Failure
Time frame: 1 to 13 months
Number of Participants With All-Cause Death
Time frame: 1 to 13 months
Number of Participants With All-Cause MI (Myocardial Infarction)
Time frame: 1 to 13 months

Results and safety

Results posted to the registry on 27 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PCI With 30 Day DAPT Therapy	50	45

Primary outcome: Number of Participants With Cardiac Death

Time frame: 1 to 13 months. Count of participants. Unit: Participants

Measure	PCI With 30 Day DAPT Therapy n = 50
Value	3

Primary outcome: Rate of Myocardial Infarction

Time frame: 1 to 13 months. Count of participants. Unit: Participants

Measure	PCI With 30 Day DAPT Therapy n = 50
Value	0

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 1 year 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCI With 30 Day DAPT Therapy	31 of 50 (62%)	44 of 50 (88%)	4 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Rizik, MD principal investigator

HonorHealth Research Institute

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Cardiac Death (time frame: 1 to 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03606642.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.