Cardiovascular DiseasePhase 4APACS-HPRNCT01339026
Evaluating Additional Platelet Inhibition in Patients With High Platelet Reactivity Undergoing Percutaneous Coronary Intervention
A Phase 4 study testing Prasugrel and Plavix in people with Cardiovascular Disease and Acute Coronary Syndrome, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in Germany.
Trial summary
Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ± stent procedure, which restores blood flow to the heart. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Acute Coronary Syndrome
- What is being tested?
- Prasugrel and Plavix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Sep 2013
- Phase
- Phase 4
- 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
- ACS patients with intent for PCI <72 hours from admission.
- Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel
- High platelet reactivity (HPR) PA > 400 AU min by multiplate analyser ("poor responders")
- Initial platelet function sample at least 2 hours after pre PCI loading dose
- Consent
Who cannot join
- Patients <18 years and >75 years
- Body weight <60kg
- Pretreatment with prasugrel within 7 days of randomisation
- History of stroke or transient ischaemic attack
- Patients with increased bleeding risk e.g.
- recent major trauma or surgery
Show all 18Show fewer
- gastrointestinal bleeding or active peptic ulceration
- Platelet count <100,000 / mm3 at the time of screening
- Internationally Normalized Ratio (INR)> 1.5 at the time of screening
- Hb<10g/dL
- Intracranial neoplasm, arteriovenous malformation or aneurysm.
- Severe hepatic impairment (Child Pugh class C)
- Intention to use the following medications
- oral anticoagulation
- other antiplatelet therapy (including GPIIb/IIIa inhibitors) besides aspirin
- nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors
- Female patients who are pregnant, planning pregnancy, not using reliable contraception or who are breastfeeding
- Known allergy, hypersensitivity or other contraindications to prasugrel or clopidogrel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Benefit of Additional Platelet Inhibition in Acute Coronary Syndrome Patients With High Platelet Reactivity Undergoing PCI
Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ± stent procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and Clopidogrel) are blood thinning treatments and research has reported they reduce heart attacks, death and stroke. The investigators know some patients do not respond fully to Clopidogrel but currently patients are not tested for this.
The investigators wish to perform a trial to identify those patients who do not respond fully to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of Clopidogrel.
Read more
Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their consent to participate. A blood sample is tested for platelet activity.
- Low platelet activity result means patient has responded well to Clopidogrel and will continue on the routine dose. They will be entered into an observational registry. Data will be collected of routine blood tests and investigations, medication and procedures. Their GP will be contacted at about 30 days to see if they are alive.
- High platelet activity results means patient has not responded fully to Clopidogrel. These patients will be randomly allocated to a higher dose of Clopidogrel or new drug Prasugrel. Data will be collected of routine blood tests and investigations, medication and procedures. A hospital visit at 30±5 days is required to assess how patients are doing, medications and occurrence of any events.
Read the detailed description
STUDY DESCRIPTION This is a multinational, randomised open label study comparing Prasugrel versus Clopidogrel in ACS patients who have high platelet reactivity managed with an early invasive strategy (PCI as early as possible and no later than 72 hours from admission).
Patients identified with low platelet reactivity indicating a good response to Clopidogrel will be entered into an observational Registry.
Sites There will be three participating hospitals, two in the UK and one in Germany.
Screening All patients admitted to the hospital with suspected ACS requiring early PCI (within 3 days of admission) will be screened for entry into the trial.
The investigator and/or his/her designee will explain the study requirements and procedures and obtain consent before any study procedures are performed.
We estimate approximately 500 patients will be screened. From these a total of 140 patients will be randomised, the remaining screened patients will be entered into the registry. There will be competitive recruitment and each site is expected to randomise about 40 to 50 patients each. We estimate 7 to 8 patients randomised per month over a period of 18 months.
Routine blood tests and investigations will be carried out according to local management strategies. The angiogram and PCI procedure are part of the routine management for this patient and will be performed according to local policies and procedures.
A research blood sample will be required to determine platelet activity which has to be taken > 2hours from the standard Clopidogrel pre-PCI loading. For most patients this will be taken in the catheter laboratory around the PCI procedure. In a few patients who are loaded with Clopidogrel close to the PCI procedure the blood samples may be taken in the ward or recovery area. Depending on the platelet activity results patients will be either entered into the registry or randomly allocated to either Clopidogrel or Prasugrel.
- Patients who are good responders to Clopidogrel (platelet reactivity <400 AUC min) will be entered into the registry.
- Patients who are poor responders to Clopidogrel (platelet reactivity > 400AUC min) will be randomised.
REGISTRY PATIENTS Patients will continue on the standard treatment of Clopidogrel. Data will be collected of routine blood tests and investigations, medication and procedures. Additional blood samples will be taken (if patient consents) for the biomarker and genetic sub-studies. Their GP will be contacted at 30±5 days to see if they are alive.
RANDOMISED PATIENTS Randomisation Investigators will access an automated telephone or automated web service. Investigators will have to confirm patient fulfils the eligibility criteria and that consent has been obtained.
Randomised Treatment Randomised patients will be allocated to receive either open label Clopidogrel (Plavix) or Prasugrel (Efient).
Group 1: Clopidogrel (Plavix)
- Day 1 Loading 600mg
- Day 2 to 7 day: 150mg o.d.
- Day 8 to 30±5 days: 75mg o.d.
Group 2: Prasugrel (Efient)
- Day 1 loading 60mg
- Day 2 to 7 10mg o.d.
- Day 8 to 30±5 days 10mg od
Drug Supply and Storage Prasugrel, a commercially available product, will be supplied by Eli Lilly which holds the manufacturing license to produce Prasugrel. Clopidogrel (Plavix) will be purchased by the hospital Pharmacy through normal purchasing arrangements. All study drugs should be stored in an appropriate locked room, under the control of the Hospital Pharmacist or the Investigator, in the conditions described in the package insert.
Hospital Admission to Discharge
- Patients will be followed until they are discharged home.
- Blood samples taken for platelet activity at 1, 4 and 24 hours, and pre-discharge.
- Blood sample for the biomarker substudy will be taken pre-PCI procedure at 24 hours and at discharge.
- Blood sample for the genetic substudy will be taken at baseline or if not possible pre-discharge.
- Patients will have instructions on how to contact the research team if they have any questions or concerns.
One Month Follow UP RCT Patients in the RCT will be required to attend the hospital for a follow up visit at 30±5 days from date of randomisation. Patients will be assessed by the investigator or his/her designee for heart rate and blood pressure, medication tolerance and compliance, occurrence of adverse events and clinical endpoints, blood sample for platelet activity. At this time the investigator will discuss with the patient their treatment options after this period.
Sub-studies There are two sub-studies proposed (i) biomarker and (ii) genetic. Blood samples will be taken and stored locally before shipment to a core lab in Germany.
- Conditions
- Cardiovascular Disease, Acute Coronary Syndrome
- Being tested
- Prasugrel, Plavix
- Keywords
- Acute coronary syndrome, Platelet reactivity, Clopidogrel, Percutaneous coronary intervention
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Also called Efient
Day 1 loading 60mg Day 2 to 7 10mg o.d. Day 8 to 30 days 10mg od
PlavixDrug
Also called Clopidogrel
Clopidogrel (Plavix) Day 1 Loading 600mg Day 2 to 7 day: 150mg o.d. Day 8 to 30 days: 75mg o.d.
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Active comparator | Day 1 loading 60mg Day 2 to 7 10mg o.d. Day 8 to 30 days 10mg od Receives: Drug: Prasugrel |
| Clopidogrel | Active comparator | Day 1 Loading 600mg Day 2 to 7 day: 150mg o.d. Day 8 to 30 days: 75mg o.d. Receives: Drug: Plavix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity
The primary endpoint will compare the proportion of patients with improved platelet response (i.e. decreased platelet reactivity under the cut-off value of 400 Au.min) in the prasugrel re-loading arm compared to the clopidogrel re-loading arm at 4 hours after randomization in patients with initial high platelet reactivity
Measured: 4 hours post loading dose
Secondary outcomes (4)
Platelet reactivity in response to randomised study drug
To compare the proportion of patients with improved platelet response between the treatment arms at hospital discharge/7 days and at 30 days.
Measured: 7 days/hospital discharge and 30 days
Extent of myocardial damage
To compare the AUC for CK and troponin at 24 hours between the treatment arms
Measured: 24 hours
MACE
To compare the rates major adverse events (death, myocardial infarction, stroke, repeated revascularization) at 30 days between the treatment arms
Measured: 30 days
Bleed
To compare the rate of major bleedings at 30 days between the treatment arms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Change in guidelines favouring newer antiplatelet drugs in ACS
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 Cardiovascular DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Miles Dalby, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation TrustTobias Geisler, MD, Principal investigator, University Hospital TuebingenAzfar Zaman, MD, Principal investigator, Freeman Hospital and University of Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339026
- Sponsor's protocol ID
- 2010-020219-35
- Acronym
- APACS-HPR
- Status last verified
- Sep 2014
- First submitted
- 19 Apr 2011
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Geisler T, Booth J, Tavlaki E, Karathanos A, Muller K, Droppa M, Gawaz M, Yanez-Lopez M, Davidson SJ, Stables RH, Banya W, Zaman A, Flather M, Dalby M. High Platelet Reactivity in Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: Randomised Controlled Trial Comparing Prasugrel and Clopidogrel. PLoS One. 2015 Aug 28;10(8):e0135037. doi: 10.1371/journal.pone.0135037. eCollection 2015.
PubMed 26317618
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Benefit of Additional Platelet Inhibition in Acute Coronary Syndrome Patients With High Platelet Reactivity Undergoing PCI
- ClinicalTrials.gov ID
- NCT01339026
- Acronym / sponsor ID
- APACS-HPR / 2010-020219-35
- Conditions
- Cardiovascular Disease, Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, Platelet reactivity, Clopidogrel, Percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in guidelines favouring newer antiplatelet drugs in ACS
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Apr 2011 (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.
Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ± stent procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and Clopidogrel) are blood thinning treatments and research has reported they reduce heart attacks, death and stroke. The investigators know some patients do not respond fully to Clopidogrel but currently patients are not tested for this.
The investigators wish to perform a trial to identify those patients who do not respond fully to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of Clopidogrel.
Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their consent to participate. A blood sample is tested for platelet activity.
- Low platelet activity result means patient has responded well to Clopidogrel and will continue on the routine dose. They will be entered into an observational registry. Data will be collected of routine blood tests and investigations, medication and procedures. Their GP will be contacted at about 30 days to see if they are alive.
- High platelet activity results means patient has not responded fully to Clopidogrel. These patients will be randomly allocated to a higher dose of Clopidogrel or new drug Prasugrel. Data will be collected of routine blood tests and investigations, medication and procedures. A hospital visit at 30±5 days is required to assess how patients are doing, medications and occurrence of any events.
Detailed description
STUDY DESCRIPTION This is a multinational, randomised open label study comparing Prasugrel versus Clopidogrel in ACS patients who have high platelet reactivity managed with an early invasive strategy (PCI as early as possible and no later than 72 hours from admission).
Patients identified with low platelet reactivity indicating a good response to Clopidogrel will be entered into an observational Registry.
Sites There will be three participating hospitals, two in the UK and one in Germany.
Screening All patients admitted to the hospital with suspected ACS requiring early PCI (within 3 days of admission) will be screened for entry into the trial.
The investigator and/or his/her designee will explain the study requirements and procedures and obtain consent before any study procedures are performed.
We estimate approximately 500 patients will be screened. From these a total of 140 patients will be randomised, the remaining screened patients will be entered into the registry. There will be competitive recruitment and each site is expected to randomise about 40 to 50 patients each. We estimate 7 to 8 patients randomised per month over a period of 18 months.
Routine blood tests and investigations will be carried out according to local management strategies. The angiogram and PCI procedure are part of the routine management for this patient and will be performed according to local policies and procedures.
A research blood sample will be required to determine platelet activity which has to be taken > 2hours from the standard Clopidogrel pre-PCI loading. For most patients this will be taken in the catheter laboratory around the PCI procedure. In a few patients who are loaded with Clopidogrel close to the PCI procedure the blood samples may be taken in the ward or recovery area. Depending on the platelet activity results patients will be either entered into the registry or randomly allocated to either Clopidogrel or Prasugrel.
- Patients who are good responders to Clopidogrel (platelet reactivity <400 AUC min) will be entered into the registry.
- Patients who are poor responders to Clopidogrel (platelet reactivity > 400AUC min) will be randomised.
REGISTRY PATIENTS Patients will continue on the standard treatment of Clopidogrel. Data will be collected of routine blood tests and investigations, medication and procedures. Additional blood samples will be taken (if patient consents) for the biomarker and genetic sub-studies. Their GP will be contacted at 30±5 days to see if they are alive.
RANDOMISED PATIENTS Randomisation Investigators will access an automated telephone or automated web service. Investigators will have to confirm patient fulfils the eligibility criteria and that consent has been obtained.
Randomised Treatment Randomised patients will be allocated to receive either open label Clopidogrel (Plavix) or Prasugrel (Efient).
Group 1: Clopidogrel (Plavix)
- Day 1 Loading 600mg
- Day 2 to 7 day: 150mg o.d.
- Day 8 to 30±5 days: 75mg o.d.
Group 2: Prasugrel (Efient)
- Day 1 loading 60mg
- Day 2 to 7 10mg o.d.
- Day 8 to 30±5 days 10mg od
Drug Supply and Storage Prasugrel, a commercially available product, will be supplied by Eli Lilly which holds the manufacturing license to produce Prasugrel. Clopidogrel (Plavix) will be purchased by the hospital Pharmacy through normal purchasing arrangements. All study drugs should be stored in an appropriate locked room, under the control of the Hospital Pharmacist or the Investigator, in the conditions described in the package insert.
Hospital Admission to Discharge
- Patients will be followed until they are discharged home.
- Blood samples taken for platelet activity at 1, 4 and 24 hours, and pre-discharge.
- Blood sample for the biomarker substudy will be taken pre-PCI procedure at 24 hours and at discharge.
- Blood sample for the genetic substudy will be taken at baseline or if not possible pre-discharge.
- Patients will have instructions on how to contact the research team if they have any questions or concerns.
One Month Follow UP RCT Patients in the RCT will be required to attend the hospital for a follow up visit at 30±5 days from date of randomisation. Patients will be assessed by the investigator or his/her designee for heart rate and blood pressure, medication tolerance and compliance, occurrence of adverse events and clinical endpoints, blood sample for platelet activity. At this time the investigator will discuss with the patient their treatment options after this period.
Sub-studies There are two sub-studies proposed (i) biomarker and (ii) genetic. Blood samples will be taken and stored locally before shipment to a core lab in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Active comparator | Drug: PrasugrelDay 1 loading 60mg Day 2 to 7 10mg o.d. Day 8 to 30 days 10mg od |
| Clopidogrel | Active comparator | Drug: PlavixDay 1 Loading 600mg Day 2 to 7 day: 150mg o.d. Day 8 to 30 days: 75mg o.d. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ACS patients with intent for PCI <72 hours from admission.
- Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel
- High platelet reactivity (HPR) PA > 400 AU min by multiplate analyser ("poor responders")
- Initial platelet function sample at least 2 hours after pre PCI loading dose
- Consent
Key exclusion criteria (18 listed)
- Patients <18 years and >75 years
- Body weight <60kg
- Pretreatment with prasugrel within 7 days of randomisation
- History of stroke or transient ischaemic attack
- Patients with increased bleeding risk e.g.
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: EfientDay 1 loading 60mg Day 2 to 7 10mg o.d. Day 8 to 30 days 10mg od | Drug | Prasugrel |
| PlavixAlso: ClopidogrelClopidogrel (Plavix) Day 1 Loading 600mg Day 2 to 7 day: 150mg o.d. Day 8 to 30 days: 75mg o.d. | Drug | Clopidogrel |
Primary outcome
Platelet Reactivity
Time frame: 4 hours post loading dose
The primary endpoint will compare the proportion of patients with improved platelet response (i.e. decreased platelet reactivity under the cut-off value of 400 Au.min) in the prasugrel re-loading arm compared to the clopidogrel re-loading arm at 4 hours after randomization in patients with initial high platelet reactivity
4 secondary outcomes
Platelet reactivity in response to randomised study drug
Time frame: 7 days/hospital discharge and 30 days
Extent of myocardial damage
Time frame: 24 hours
MACE
Time frame: 30 days
Bleed
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Change in guidelines favouring newer antiplatelet drugs in ACS). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Derived from this study: PubMed 26317618Geisler T, Booth J, Tavlaki E, Karathanos A, Muller K, Droppa M, Gawaz M, Yanez-Lopez M, Davidson SJ, Stables RH, Banya W, Zaman A, Flather M, Dalby M. High Platelet Reactivity in Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: Randomised Controlled Trial Comparing Prasugrel and Clopidogrel. PLoS One. 2015 Aug 28;10(8):e0135037. doi: 10.1371/journal.pone.0135037. eCollection 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.
Miles Dalby, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
Tobias Geisler, MD principal investigator
University Hospital Tuebingen
Azfar Zaman, MD principal investigator
Freeman Hospital and University of Newcastle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel and Plavix in people with Cardiovascular Disease and Acute Coronary Syndrome, run by Royal Brompton & Harefield NHS Foundation Trust 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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Sep 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Change in guidelines favouring newer antiplatelet drugs in ACS). Results are not available in the source record.
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?
Platelet Reactivity (time frame: 4 hours post loading dose). 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 NCT01339026, 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 Sep 2014.