Acute Coronary SyndromePhase 3NCT01774838
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
A Phase 3 study testing Prasugrel and Clopidogrel in people with Acute Coronary Syndrome and Unstable Angina, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Unstable Angina
- What is being tested?
- Prasugrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute coronary syndrome, unstable angina
- planned percutaneous coronary intervention
- Written informed consent
Who cannot join
- - 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Acute Coronary Syndrome, Unstable Angina
- Being tested
- Prasugrel, Clopidogrel
- Medical subject headings
- Acute Coronary Syndrome, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Also called Efient
3 months treatment
ClopidogrelDrug
Also called Plavix
3 months treatment
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Experimental | 3 months treatment with 10 mg prasugrel Receives: Drug: Prasugrel |
| Clopidogrel | Active comparator | 3 months treatment with clopidogrel 75 mg Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanja Rudolph, University of Cologne
- Investigators
- Tanja Rudolph, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774838
- Sponsor's protocol ID
- Uni-Koeln-1649
- Status last verified
- Jun 2015
- First submitted
- 16 Jan 2013
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01774838
- Acronym / sponsor ID
- Uni-Koeln-1649
- Conditions
- Acute Coronary Syndrome, Unstable Angina
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Experimental | Drug: Prasugrel3 months treatment with 10 mg prasugrel |
| Clopidogrel | Active comparator | Drug: Clopidogrel3 months treatment with clopidogrel 75 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute coronary syndrome, unstable angina
- planned percutaneous coronary intervention
- Written informed consent
Key exclusion criteria (22 listed)
- - Age < 18 years or ≥75 years
- Body weight < 60 kg
- STEMI, NSTEMI
- Cardiogenic shock at the time of randomization
- Refractory ventricular arrhythmias
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 |
|---|---|---|
| PrasugrelAlso: Efient3 months treatment | Drug | Prasugrel |
| ClopidogrelAlso: Plavix3 months treatment | Drug | Clopidogrel |
Primary outcome
Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer
Time frame: baseline and after 3 months
The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
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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.
Tanja Rudolph, MD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prasugrel and Clopidogrel in people with Acute Coronary Syndrome and Unstable Angina, run by University of Cologne at 1 site in Germany.
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 3 inclusion and 22 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: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer (time frame: baseline and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2015.