Patients With Acute Coronary SyndromeNCT01090336
Prasugrel Versus Clopidogrel in Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
An observational study of Patients With Acute Coronary Syndrome, run by Heidelberg University at 1 site in Germany.
Trial summary
Background: Both prasugrel and clopidogrel are prescribed drugs which compete as platelet inhibitors in patients with acute coronary syndrome (ACS). Whether rates of drug resistance/hyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Acute Coronary Syndrome
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Dec 2011
- Phase
- Observational
- 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
Study population: The study population includes 80 subjects with moderate to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment elevation MI (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of symptoms. In all patients early PCI is planned. Patients with exclusion criteria for prasugrel will be excluded for clopidogrel as well.
Who may be able to join
- Patients with unstable angina or non-ST-elevation myocardial infarction with ischemic symptoms lasting 10 minutes or more and occurring within 72 hours before randomization,
- A TIMI risk score of 3 or more, and
- Either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis.
- Legal age (and ≥18 y) and competent mental condition to provide written informed consent
Who cannot join
- Patients with weight < 60 kg, age > 75 year or history of TIA, stroke or intracranial bleeding according to prasugrel contraindications
- Clinical status forbid inclusion (eg cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, New York Heart Association class IV congestive heart failure etc)
- Bleeding risk exclusion criteria including fibrin-specific and non-fibrin-specific fibrinolytic therapy for index event, active internal bleeding or history of bleeding diathesis or any clinical findings in the judgment of the investigator associated with an increased risk of bleeding
- History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation, or aneurysm
- Ischemic stroke within 3 months prior to screening
- Oral anticoagulation or INR greater than 1.5 at the time of screening
Show all 10Show fewer
- Platelet count of less than 100 000/mm3 at the time of screening
- Anemia (hemoglobin <10 g/dL) at the time of screening
- Prior/concomitant therapy with thienopyridine or daily treatment with nonsteroidal antiinflammatory drugs or cyclooxygenase-2 inhibitors
- General exclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Evangelos Giannitsis, Prof. Dr., +49 (0)6221-56-8611, Evangelos_Giannitsis@med.uni-heidelberg.de
Kerstin Kurz, Dr.
About this study
Official title: Prevalence of Inadequate Platelet Inhibition After Oral Loading With Prasugrel/Clopidogrel in Patients With an Acute Coronary Syndrome Undergoing Early PCI
Background: Both prasugrel and clopidogrel are prescribed drugs which compete as platelet inhibitors in patients with acute coronary syndrome (ACS). Whether rates of drug resistance/hyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size in patients with ACS undergoing early PCI remains, at present, unknown.
Study design/study population: This trial is a prospective, open-label, single centre observational trial. Patients receive either prasugrel (60mg) or clopidogrel (600mg) at the discretion of the attending cardiologist. Patients with exclusion criteria for prasugrel will be excluded for clopidogrel as well. The study population includes 80 subjects with moderate to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment elevation MI (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of symptoms. In all patients early PCI is planned.
Read more
Study objective/endpoint/methods: The primary objective of this trial is to evaluate whether rates of hyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size in ACS in patients undergoing early PCI.
The primary endpoint is the rate of drug resistance at time of index intervention. Optical and impedance aggregometry using ADP (5 and 20 μM) and collagen (1 μg/ml) as platelet agonists is used to measure platelet aggregation. Addition of the specific antagonists aspirin and mesamp to the probe is used to discriminate between pharmacodynamic and pharmacokinetic drug resistance.
Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT (TnT hs) during the days following the index event reflecting earlier, more effective and more consistent inhibition of platelet function.
Tertiary endpoint is the composite clinical endpoint of cardiovascular death, nonfatal MI, or stroke and urgent target vessel revascularization during hospitalization and after 6 and 12 months.
Safety endpoint is any TIMI major or minor bleeding during hospital stay and after 6 and 12 months including intracranial and life-threatening bleeding.
Read the detailed description
look above
- Conditions
- Patients With Acute Coronary Syndrome
- Keywords
- platelet aggregation inhibition, prasugrel, clopidogrel, ACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel group | At the discretion of the attending cardiologist patients are treated with clopidogrel (600mg loading and 75mg daily dose) | |
| Prasugrel group | At the discretion of the attending cardiologist patients are treated with prasugrel (60mg loading and 10mg daily dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the rate of drug resistance at time of index intervention.
Platelet aggregation is determined by light transmission and impedance aggregometry as previoulsy described (Boris T. Ivandic, Philipp Schlick, Peter Staritz, Kerstin Kurz, Hugo A. Katus and Evangelos Giannitsis: Determination of Clopidogrel Resistance by Whole Blood Platelet Aggregometry and Inhibitors of the P2Y12 Receptor; Clinical Chemistry 52: 383-388, 2006)
Measured: Routinely, platelet aggregation is evaluated ideally daily up to 96 hours after index event.
Secondary outcomes (1)
Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT (TnT hs).
Measured: Routinely, ideally daily until 96h after index event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startAug 2009
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Investigators
- Evangelos Giannitsis, Prof. Dr., Principal investigator, Department of Cardiology, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090336
- Sponsor's protocol ID
- PC01
- Other IDs
- S-235/2009
- Status last verified
- Mar 2010
- First submitted
- 16 Mar 2010
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ivandic BT, Schlick P, Staritz P, Kurz K, Katus HA, Giannitsis E. Determination of clopidogrel resistance by whole blood platelet aggregometry and inhibitors of the P2Y12 receptor. Clin Chem. 2006 Mar;52(3):383-8. doi: 10.1373/clinchem.2005.059535. Epub 2006 Jan 19.
PubMed 16423907
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Inadequate Platelet Inhibition After Oral Loading With Prasugrel/Clopidogrel in Patients With an Acute Coronary Syndrome Undergoing Early PCI
- ClinicalTrials.gov ID
- NCT01090336
- Acronym / sponsor ID
- PC01
- Conditions
- Patients With Acute Coronary Syndrome
- Keywords
- platelet aggregation inhibition, prasugrel, clopidogrel, ACS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Study start
- Aug 2009
- Study completion
- Dec 2011 (estimated)
- First posted
- 19 Mar 2010 (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.
Background: Both prasugrel and clopidogrel are prescribed drugs which compete as platelet inhibitors in patients with acute coronary syndrome (ACS). Whether rates of drug resistance/hyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size in patients with ACS undergoing early PCI remains, at present, unknown.
Study design/study population: This trial is a prospective, open-label, single centre observational trial. Patients receive either prasugrel (60mg) or clopidogrel (600mg) at the discretion of the attending cardiologist. Patients with exclusion criteria for prasugrel will be excluded for clopidogrel as well. The study population includes 80 subjects with moderate to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment elevation MI (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of symptoms. In all patients early PCI is planned.
Study objective/endpoint/methods: The primary objective of this trial is to evaluate whether rates of hyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size in ACS in patients undergoing early PCI.
The primary endpoint is the rate of drug resistance at time of index intervention. Optical and impedance aggregometry using ADP (5 and 20 μM) and collagen (1 μg/ml) as platelet agonists is used to measure platelet aggregation. Addition of the specific antagonists aspirin and mesamp to the probe is used to discriminate between pharmacodynamic and pharmacokinetic drug resistance.
Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT (TnT hs) during the days following the index event reflecting earlier, more effective and more consistent inhibition of platelet function.
Tertiary endpoint is the composite clinical endpoint of cardiovascular death, nonfatal MI, or stroke and urgent target vessel revascularization during hospitalization and after 6 and 12 months.
Safety endpoint is any TIMI major or minor bleeding during hospital stay and after 6 and 12 months including intracranial and life-threatening bleeding.
Detailed description
look above
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel group | – | –At the discretion of the attending cardiologist patients are treated with clopidogrel (600mg loading and 75mg daily dose) |
| Prasugrel group | – | –At the discretion of the attending cardiologist patients are treated with prasugrel (60mg loading and 10mg daily dose) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes 80 subjects with moderate to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment elevation MI (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of symptoms. In all patients early PCI is planned. Patients with exclusion criteria for prasugrel will be excluded for clopidogrel as well.
Key inclusion criteria (4 listed)
- Patients with unstable angina or non-ST-elevation myocardial infarction with ischemic symptoms lasting 10 minutes or more and occurring within 72 hours before randomization,
- A TIMI risk score of 3 or more, and
- Either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis.
- Legal age (and ≥18 y) and competent mental condition to provide written informed consent
Key exclusion criteria (10 listed)
- Patients with weight < 60 kg, age > 75 year or history of TIA, stroke or intracranial bleeding according to prasugrel contraindications
- Clinical status forbid inclusion (eg cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, New York Heart Association class IV congestive heart failure etc)
- Bleeding risk exclusion criteria including fibrin-specific and non-fibrin-specific fibrinolytic therapy for index event, active internal bleeding or history of bleeding diathesis or any clinical findings in the judgment of the investigator associated with an increased risk of bleeding
- History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation, or aneurysm
- Ischemic stroke within 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint is the rate of drug resistance at time of index intervention.
Time frame: Routinely, platelet aggregation is evaluated ideally daily up to 96 hours after index event.
Platelet aggregation is determined by light transmission and impedance aggregometry as previoulsy described (Boris T. Ivandic, Philipp Schlick, Peter Staritz, Kerstin Kurz, Hugo A. Katus and Evangelos Giannitsis: Determination of Clopidogrel Resistance by Whole Blood Platelet Aggregometry and Inhibitors of the P2Y12 Receptor; Clinical Chemistry 52: 383-388, 2006)
1 secondary outcome
Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT (TnT hs).
Time frame: Routinely, ideally daily until 96h after index event.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
- Results publication: PubMed 16423907Ivandic BT, Schlick P, Staritz P, Kurz K, Katus HA, Giannitsis E. Determination of clopidogrel resistance by whole blood platelet aggregometry and inhibitors of the P2Y12 receptor. Clin Chem. 2006 Mar;52(3):383-8. doi: 10.1373/clinchem.2005.059535. Epub 2006 Jan 19.
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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.
University of Heidelberg
Heidelberg, Germany
Evangelos Giannitsis, Prof. Dr. principal investigator
Department of Cardiology, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Acute Coronary Syndrome, run by Heidelberg University 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Apr 2011. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the rate of drug resistance at time of index intervention. (time frame: Routinely, platelet aggregation is evaluated ideally daily up to 96 hours after index event.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090336, which also lists 1 linked publication.
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 18 Apr 2011.