Back to resultsVasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome, Unstable Angina
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Prasugrel
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome
Eligibility Criteria
Inclusion Criteria:
- Acute coronary syndrome, unstable angina
- planned percutaneous coronary intervention
- Written informed consent
Exclusion Criteria:
- - Age < 18 years or ≥75 years
- Body weight < 60 kg
- STEMI, NSTEMI
- Cardiogenic shock at the time of randomization
- Refractory ventricular arrhythmias
- Congestive heart failure (NYHA IV)
- Increased risk of bleeding
- Active internal bleeding or history of hemorrhagic diathesis
- History of TIA, ischemic or hemorrhagic stroke
- Intracranial neoplasm, aneurysm and arteriovenous malformation
- INR > 1.5 at screening
- Platelets < 100,000/ml
- Anemia (Hb < 10 g/dl) at screening
- One or more doses of a thienopyridine 5 d or less before PCI
- Oral anticoagulation which cannot be safely discontinued for the duration of the study
- One or more doses of a thienopyridine 5 d or less before PCI
- Treatment within the last 30 d with an investigational drug or are presently enrolled in another drug or device study
- Women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding
- Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period
- Known severe hepatic dysfunction
- Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence
- Intolerance of or allergy to aspirin, ticlopidine, or clopidogrel
Sites / Locations
- Cardiology, University Hospital of Cologne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prasugrel
Clopidogrel
Arm Description
3 months treatment with 10 mg prasugrel
3 months treatment with clopidogrel 75 mg
Outcomes
Primary Outcome Measures
Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer
The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01774838
Brief Title
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Official Title
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute coronary syndrome endothelial function -as a surrogate parameter of NO bioavailability- and different markers of inflammation, oxidative stress and platelet activation will be assessed in patients with unstable angina.
Detailed Description
Trial Objectives To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute coronary syndrome, endothelial function -as a surrogate parameter of NO bioavailability- and different markers of inflammation, oxidative stress and platelet activation will be assessed in patients with unstable angina.
Trial Design Single center, double blind, double-dummy, randomized, parallel trial.
Endpoints
Primary Endpoint Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer.
Secondary Endpoints
Non-invasive assessment of microvascular perfusion and oxygen saturation by laser Doppler perfusion imaging and tissue spectrometry (O2C, Lea Medizintechnik, Giessen, Germany)
Determination of leukocyte activity: plasma MPO levels (ELISA), plasma elastase levels (ELISA)
Assessment of platelet activity: plasma levels of sCD40 ligand (ELISA), RANTES (ELISA)
Measurement of different oxidative stress markers: hsCRP (ELISA), CD40 ligand (ELISA), carbonylated proteins (ELISA), urinary 8-iso-PGF2α (gas chromatography mass spectrometry)
Determination of platelet-leukocyte aggregates by fluorescent activated cell sorter (FACS)
Assessment of platelet function (PADA-test)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Unstable Angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prasugrel
Arm Type
Experimental
Arm Description
3 months treatment with 10 mg prasugrel
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
3 months treatment with clopidogrel 75 mg
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Other Intervention Name(s)
Efient
Intervention Description
3 months treatment
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
3 months treatment
Primary Outcome Measure Information:
Title
Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer
Description
The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.
Time Frame
baseline and after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute coronary syndrome, unstable angina
planned percutaneous coronary intervention
Written informed consent
Exclusion Criteria:
- Age < 18 years or ≥75 years
Body weight < 60 kg
STEMI, NSTEMI
Cardiogenic shock at the time of randomization
Refractory ventricular arrhythmias
Congestive heart failure (NYHA IV)
Increased risk of bleeding
Active internal bleeding or history of hemorrhagic diathesis
History of TIA, ischemic or hemorrhagic stroke
Intracranial neoplasm, aneurysm and arteriovenous malformation
INR > 1.5 at screening
Platelets < 100,000/ml
Anemia (Hb < 10 g/dl) at screening
One or more doses of a thienopyridine 5 d or less before PCI
Oral anticoagulation which cannot be safely discontinued for the duration of the study
One or more doses of a thienopyridine 5 d or less before PCI
Treatment within the last 30 d with an investigational drug or are presently enrolled in another drug or device study
Women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding
Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period
Known severe hepatic dysfunction
Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence
Intolerance of or allergy to aspirin, ticlopidine, or clopidogrel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Rudolph, MD
Organizational Affiliation
University Hospital of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology, University Hospital of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
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