Angina PectorisPhase 4SASSICAIANCT02548611
Comparison of Loading Strategies With Antiplatelet Drugs in Patients Undergoing Elective Coronary Intervention
A Phase 4 study testing Prasugrel and Clopidogrel in people with Angina Pectoris, run by LMU Klinikum at 5 sites in 2 countries.
Trial summary
Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting. However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Prasugrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 795 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2015to Nov 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biomarker negative stable or unstable angina pectoris
- Written informed consent
- In women with childbearing potential a pregnancy test is obligatory
Who cannot join
- Age < 18 years and >80 years
- ST-elevation MI
- Elevated cardiac biomarkers
- Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage and with known severe liver disease (Child Pugh Class C)
- Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke and with known severe liver disease (Child Pugh Class C)
- Chronic therapy on potent P2Y12 receptor inhibitors (ticagrelor, prasugrel)
Show all 12Show fewer
- Pre-treatment with a loading dose of either clopidogrel, prasugrel or ticagrelor
- Simultaneous participation in another clinical trial that involves the administration of an investigational medicinal drug within 30 days prior to the start of this clinical trial
- Major surgeries in the last 6 weeks and planned surgeries within the next 6 weeks (per decision of the treating physician)
- Active bleeding
- Known or persistent abuse of medication, drugs or alcohol
- Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Universitäts-Herzzentrum Freiburg, Bad Krozingen
Freiburg im Breisgau, Bad Krozingen, 79189
Munich University Hospital
Munich, Bavaria, 81377
Deutsches Herzzentrum Muenchen
Munich, 80636
Klinikum Bogenhausen
Munich
Hungary1 site
Heart Center Balatonfüred and Heart and Vascular Center
Balatonfüred
About this study
Official title: Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris
Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting. However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable. A way to overcome this limitation is loading with a more potent antiplatelet drug such as prasugrel. Therefore in the current study the investigators want to compare loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug) in patients undergoing elective coronary intervention.
Read the detailed description
Patients with stable or clinically unstable (biomarker-negative) angina pectoris who are in need of coronary intervention will be randomly assigned in one of the treatment strategies - 60 mg of prasugrel or 600 mg clopidogrel just prior to percutaneous coronary intervention (PCI). After PCI all patients will receive clopidogrel 75 mg/d as per standard. The patients will be monitored throughout a 30-day time frame and ischemic and bleeding events will be recorded. The study is powered to show the superiority of single-dose 60 mg prasugrel over single-dose 600 mg clopidogrel regarding the ischemic complications at 30-day follow-up.
- Conditions
- Angina Pectoris
- Being tested
- Prasugrel, Clopidogrel
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Also called Efient
see arm description
ClopidogrelDrug
Also called Iscover, Plavix
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Experimental | single-dose loading with 60 mg of prasugrel pre PCI Receives: Drug: Prasugrel |
| Clopidogrel | Active comparator | loading with 600 mg of clopidogrel pre PCI Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined ischemic events
Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke
Measured: 30 days
Secondary outcomes (7)
Bleeding
Academic Research Consortium ≥2 bleeding and TIMI classification
Measured: 30 days
Peri-PCI MI Type 4a
according to Third Universal Definition of MI
Measured: 30 days
All-cause death
mortality
Measured: 30 days
Any myocardial infarction
according to SASSICAIA protocol definition
Measured: 30 days
Stent thrombosis
according to Academic Research Consortium criteria
Measured: 30 days
Urgent vessel revascularization
revascularization related to symptoms
Measured: 30 days
cerebro-vascular events
stroke and TIA
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 posted14 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2018
- Study completionNov 2018
Why it stopped: Due to low recruitment
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 Angina PectorisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 795 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Julinda Mehilli, LMU Klinikum
- Investigators
- Julinda Mehilli, MD, Principal investigator, University Hospital Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548611
- Sponsor's protocol ID
- GE IDE MucT002-14
- Acronym
- SASSICAIA
- Status last verified
- Jul 2020
- First submitted
- 10 Sep 2015
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mehilli J, Baquet M, Hochholzer W, Mayer K, Tesche C, Aradi D, Xu Y, Thienel M, Gschwendtner S, Zadrozny M, Jochheim D, Sibbing D, Schupke S, Mansmann U, Hoffmann E, Kastrati A, Neumann FJ, Massberg S. Randomized Comparison of Intensified and Standard P2Y12-Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008649. doi: 10.1161/CIRCINTERVENTIONS.119.008649. Epub 2020 Jun 12.
PubMed 32527192
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris
- ClinicalTrials.gov ID
- NCT02548611
- Acronym / sponsor ID
- SASSICAIA / GE IDE MucT002-14
- Conditions
- Angina Pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruitment
- Enrolment
- 795 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 14 Sep 2015 (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.
Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting. However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable. A way to overcome this limitation is loading with a more potent antiplatelet drug such as prasugrel. Therefore in the current study the investigators want to compare loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug) in patients undergoing elective coronary intervention.
Detailed description
Patients with stable or clinically unstable (biomarker-negative) angina pectoris who are in need of coronary intervention will be randomly assigned in one of the treatment strategies - 60 mg of prasugrel or 600 mg clopidogrel just prior to percutaneous coronary intervention (PCI). After PCI all patients will receive clopidogrel 75 mg/d as per standard. The patients will be monitored throughout a 30-day time frame and ischemic and bleeding events will be recorded. The study is powered to show the superiority of single-dose 60 mg prasugrel over single-dose 600 mg clopidogrel regarding the ischemic complications at 30-day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Experimental | Drug: Prasugrelsingle-dose loading with 60 mg of prasugrel pre PCI |
| Clopidogrel | Active comparator | Drug: Clopidogrelloading with 600 mg of clopidogrel pre PCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with biomarker negative stable or unstable angina pectoris
- Written informed consent
- In women with childbearing potential a pregnancy test is obligatory
Key exclusion criteria (12 listed)
- Age < 18 years and >80 years
- ST-elevation MI
- Elevated cardiac biomarkers
- Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage and with known severe liver disease (Child Pugh Class C)
- Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke and with known severe liver disease (Child Pugh Class C)
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: Efientsee arm description | Drug | Prasugrel |
| ClopidogrelAlso: Iscover, Plavixsee arm description | Drug | Clopidogrel |
Primary outcome
Combined ischemic events
Time frame: 30 days
Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke
7 secondary outcomes
Bleeding
Time frame: 30 days
Peri-PCI MI Type 4a
Time frame: 30 days
All-cause death
Time frame: 30 days
Any myocardial infarction
Time frame: 30 days
Stent thrombosis
Time frame: 30 days
Urgent vessel revascularization
Time frame: 30 days
cerebro-vascular events
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Due to low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Derived from this study: PubMed 32527192Mehilli J, Baquet M, Hochholzer W, Mayer K, Tesche C, Aradi D, Xu Y, Thienel M, Gschwendtner S, Zadrozny M, Jochheim D, Sibbing D, Schupke S, Mansmann U, Hoffmann E, Kastrati A, Neumann FJ, Massberg S. Randomized Comparison of Intensified and Standard P2Y12-Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008649. doi: 10.1161/CIRCINTERVENTIONS.119.008649. Epub 2020 Jun 12.
- Individual participant dataSharing planned: No
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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.
Julinda Mehilli, MD principal investigator
University Hospital Munich
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel and Clopidogrel in people with Angina Pectoris, run by LMU Klinikum at 5 sites in 2 countries.
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 12 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Hungary. 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: Due to low recruitment). 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?
Combined ischemic events (time frame: 30 days). 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 NCT02548611, 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 17 Jul 2020.