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Antiplatelet Agent
Synergy® Stent + DAPT for Coronary Artery Disease (SYNIVUS-DAPT Trial)
Phase 2
Waitlist Available
Led By David Rizik, MD
Research Sponsored by HonorHealth Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 13 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trial will test if a new stent is safe for patients who are at high risk for bleeding.
Who is the study for?
This trial is for adults at high risk of bleeding who need a stent due to coronary artery disease. They must be able to take dual antiplatelet therapy, have had a Synergy Stent implanted with IVUS guidance, and agree to follow the study rules. Exclusions include active ulcers, other clinical trials participation, certain allergies, pregnancy or nursing women, and various medical conditions.
What is being tested?
The study tests if one month of dual antiplatelet therapy (DAPT) combined with Synergy® Stent placement using intravascular ultrasound (IVUS) is safe for patients prone to bleeding. The focus is on the safety of short-term DAPT after stenting.
What are the potential side effects?
Potential side effects may include bleeding complications due to the antiplatelet drugs and risks associated with stent implantation like blood vessel damage or reaction to the stent material.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 to 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 13 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of cardiac death
Rate of myocardial infarction
Secondary study objectives
All-Cause Death
All-Cause MI
ID Target Vessel Revascularization
+5 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PCI with 30 day DAPT TherapyExperimental Treatment2 Interventions
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)
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Who is running the clinical trial?
HonorHealth Research InstituteLead Sponsor
25 Previous Clinical Trials
856 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
743 Previous Clinical Trials
857,412 Total Patients Enrolled
82 Trials studying Coronary Artery Disease
99,054 Patients Enrolled for Coronary Artery Disease
David Rizik, MDPrincipal InvestigatorHonorHealth Research Institute
3 Previous Clinical Trials
1,537 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
100 Patients Enrolled for Coronary Artery Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a blood clot, or a potential blood clot, in the specific blood vessel being studied.You are currently taking part in a research study for a new medication or medical device that has not finished its main goal.The target lesion has a complicated split or division.You need treatment for more than two large heart blood vessels.You currently have a stomach ulcer or bleeding in your stomach or intestines.You have had a Synergy Stent implanted and used Boston Scientific IVUS to guide the stent implantation.Any stents that were placed in the body must meet certain criteria for success when examined with a special imaging test called IVUS.The blood vessel must be between 2.25 mm and 4.0 mm in diameter, and the affected area must be no longer than 34mm.You have a condition called Non ST elevation MI (NSTEMI) according to a specific medical definition.You have received a different type of coronary stent, other than the SYNERGY Stent, during a previous procedure.You have received intravascular brachytherapy treatment before.You are not able to stop taking a certain type of medication called P2Y12 inhibitor after one month.You have received a drug-coated stent other than SYNERGY Stent within 11 months before the study.Your blood flow in a specific artery is completely blocked.You are at a high risk for bleeding based on certain criteria.You have blockages in more than three arteries around your heart, unless they can all be treated with one stent.The area where a stent was placed in your body has become narrow again.You have received treatment for lesions that are not the main focus of the study or were not treated with a Synergy stent.You did not have a stent implanted and assessed using Boston Scientific IVUS guidance.Any specific abnormal area in your body that has not been treated with a certain type of medical procedure.The area to be treated is in a vein or artery that has been surgically replaced.The tumor is in the left main part of the body.You have a surgery or procedure coming up that will require you to stop taking a certain medication for at least one month.You have a medical condition that doctors expect to significantly shorten your life.You have a condition called acute ST elevation myocardial infarction (STEMI).You have a scheduled surgery more than 7 days after the first procedure.
Research Study Groups:
This trial has the following groups:- Group 1: PCI with 30 day DAPT Therapy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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