Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00132912
Other study ID # P03573
Secondary ID
Status Completed
Phase Phase 2
First received August 19, 2005
Last updated May 23, 2017
Start date August 30, 2005
Est. completion date January 28, 2007

Study information

Verified date May 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
SCH 530348


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

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
See also
  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