Coronary Disease Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
Verified date | May 2017 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The object of the study is to determine whether different doses of SCH 530348, when added to
standard medical care in persons undergoing percutaneous coronary intervention, will
increase the risk of bleeding.
A secondary objective is to determine whether patients treated with SCH 530348 have fewer
cardiac events such as heart attack, bypass surgery, or death compared with those persons
treated with the standard of care.
Status | Completed |
Enrollment | 1030 |
Est. completion date | January 28, 2007 |
Est. primary completion date | January 28, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - A person who is 45 years or older and is mentally competent to provide a signed written informed consent. - A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention. - If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control. Exclusion Criteria: - Pregnancy - Recent stroke - Active internal bleeding or a history of a bleeding disorder - Increased risk of bleeding - Severe high blood pressure - Liver or kidney disease - Low platelet count - Condition such as alcoholism, mental illness, or drug dependence - Ongoing chest pain - Planned or ongoing treatment with a blood thinning medication - A serious condition or illness that would interfere with participation in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention | |||
Secondary | Incidence of bleeding throughout treatment and follow-up | |||
Secondary | Incidence of death and major adverse cardiac events |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Completed |
NCT05672862 -
International Post-PCI FFR Extended Registry
|
||
Completed |
NCT04492423 -
VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
|
||
Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
Completed |
NCT00046410 -
Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting
|
N/A | |
Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
Not yet recruiting |
NCT02895009 -
Hemostatic Compression Patterns After Transradial Coronary Intervention
|
N/A | |
Completed |
NCT02948517 -
Time Restricted Feeding for Weight Loss and Cardio-protection
|
N/A | |
Completed |
NCT02784873 -
High Intensity Interval Training in UK Cardiac Rehabilitation Programmes
|
N/A | |
Recruiting |
NCT02859480 -
Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI
|
Phase 4 | |
Withdrawn |
NCT02418143 -
A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope
|
||
Completed |
NCT02510547 -
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
|
Phase 4 | |
Completed |
NCT02382731 -
Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
|
N/A | |
Recruiting |
NCT01681381 -
Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization
|
N/A | |
Completed |
NCT02248415 -
Administration of Warm Blood Cardioplegia With or Without Roller Pump
|
N/A | |
Recruiting |
NCT01207167 -
Mediators of Atherosclerosis in South Asians Living in America
|
||
Completed |
NCT02088138 -
Functional Electrical Stimulation in Cardiac Patients
|
N/A | |
Completed |
NCT02173067 -
Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
|
N/A | |
Completed |
NCT02133807 -
Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis
|
Phase 3 |