Coronary DiseaseNCT04251039
in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"
An observational study of Coronary Disease, run by Fondazione GISE Onlus at 1 site in Italy.
Trial summary
Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI. Prospective, observational, multicenter registry. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Disease
- Type of treatment
- Injection or infusion
- How many people
- 550 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2022to Dec 2023
- How long will I take part?
- 1 Month
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with SCAD undergoing complex PCI
Who may be able to join
- Patient must be at least 65 years of age at the time of signing the Informed Consent Form
- Patient presenting with SCAD undergoing complex PCI and:
- Type 2 Diabetes Mellitus;
- CKD (Grade specified in CRF);
- Complex SCAD: LMD, 3VD, bifurcation lesions, Rotablator, CTO, multiple Stents, total length of the stents must be greater than 60 mm.
- Patient is to be treated for de novo lesions located in previously untreated vessels.
- Patient must agree to undergo all required follow-up visits and data collection.
Who cannot join
- History of CABG;
- In stent restenosis;
- Patient with intolerance or contra-indications to treatment with aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, heparin, contrast media;
- Patient on chronic treatment with oral anticoagulants;
- Patient with neoplastic or rheumatic diseases;
- Use of dipyridamole, cilostazol, or anticoagulant therapy during the study period;
Show all 15Show fewer
- Bleeding disorder
- History of an ischemic stroke or intracranial bleeding
- Intracranial vascular abnormality;
- Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days.
- Women who are pregnant/breastfeeding or who have the potential to become pregnant during the study;
- Patient with bleeding diathesis in whom antiplatelet drug is contraindicated;
- Concomitant indication to open heart surgery
- Inability to provide written informed consent
- Enrolment in another study within 1 month
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale Santa Maria
Bari, Apulia, 70124
Alfredo Marchese, MD, PhD
Alfredo Marchese, MD, PhD
About this study
Official title: "Efficacy and Safety of Oral/iv Therapy (Cangrelor) in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"
Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI.
Prospective, observational, multicenter registry.
Read the detailed description
SCAD patients routinely in the Italian centers undergo complex PCIs with pre-treatment with P2Y12 inhibitors or with P2Y12 inhibitors administration after procedure. This implies that participants receive interventions as part of routine medical care, and that researchers actually observe the effect of the intervention.
- Conditions
- Coronary Disease
- Medical subject headings
- Coronary Disease
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 |
|---|---|---|
| PCI with pre-treatment with P2Y12 inhibitors | SCAD patients undergoing complex PCI with pre-treatment with P2Y12 inhibitors will undergo: * Assessment of platelet reactivity (Time 0, T0) (VFN) * PCI (start = T1; end= T2) | |
| PCI with treatment with P2Y12 inhibitors only after procedure. | SCAD patients undergoing complex PCI with treatment with P2Y12 inhibitors only after procedure will undergo: * Administration of Cangrelor (bolus + infusion of at least 2 hours and at least until end of PCI) or decision to not administer (T0) * Assessment of platelet reactivity (Time 0, T0) (VFN) * PCI (start of PCI= T1; end of infusion of Cangrelor= T2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification.
Number of patients with intracranial hemorrhage or a ≥5 g/dl decrease in hemoglobin concentration or a ≥15 % absolute decrease in hematocrit.
Measured: hour 48
Secondary outcomes (5)
Efficacy endpoint: Long-term major adverse cardiac and cerebrovascular events MACCE (eg Death from any cause, Any Myocardial infarction, Revascularization, Stroke)
Number of patients with Long-term major adverse cardiac and cerebrovascular events (MACCE) (e.g. Death from any cause, Any Myocardial infarction, Revascularization, Stroke)
Measured: hour 48 and day 30
Assessment of platelet reactivity
Assessment of platelet reactivity measured by the VerifyNow® P2Y12 assay. Pharmacodynamic measurements will occur according to manufacturer instructions before, during, and after study drug infusion.
Measured: Day 0
Number of Participants with stent thrombosis
Number of Participants with stent thrombosis demonstrated by coronary angiography
Measured: hour 48
Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.
Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.
Measured: Day 30
Time to Coronary Artery Bypass Graft (CABG)
Time between the intervention and the Coronary Artery Bypass Graft (CABG)
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fondazione GISE Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfredo Marchese, MD, PhD, Principal investigator, Ospedale Santa Maria (BA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251039
- Sponsor's protocol ID
- RESPONSE V 0.4 31/10/2019
- Status last verified
- Jul 2022
- First submitted
- 3 Jan 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy and Safety of Oral/iv Therapy (Cangrelor) in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"
- ClinicalTrials.gov ID
- NCT04251039
- Acronym / sponsor ID
- RESPONSE V 0.4 31/10/2019
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Fondazione GISE OnlusUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Jan 2020 (actual)
- 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.
Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI.
Prospective, observational, multicenter registry.
Detailed description
SCAD patients routinely in the Italian centers undergo complex PCIs with pre-treatment with P2Y12 inhibitors or with P2Y12 inhibitors administration after procedure. This implies that participants receive interventions as part of routine medical care, and that researchers actually observe the effect of the intervention.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI with pre-treatment with P2Y12 inhibitors | – | –SCAD patients undergoing complex PCI with pre-treatment with P2Y12 inhibitors will undergo: * Assessment of platelet reactivity (Time 0, T0) (VFN) * PCI (start = T1; end= T2) |
| PCI with treatment with P2Y12 inhibitors only after procedure. | – | –SCAD patients undergoing complex PCI with treatment with P2Y12 inhibitors only after procedure will undergo: * Administration of Cangrelor (bolus + infusion of at least 2 hours and at least until end of PCI) or decision to not administer (T0) * Assessment of platelet reactivity (Time 0, T0) (VFN) * PCI (start of PCI= T1; end of infusion of Cangrelor= T2) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with SCAD undergoing complex PCI
Key inclusion criteria (7 listed)
- Patient must be at least 65 years of age at the time of signing the Informed Consent Form
- Patient presenting with SCAD undergoing complex PCI and:
- Patient is to be treated for de novo lesions located in previously untreated vessels.
- Patient must agree to undergo all required follow-up visits and data collection.
Key exclusion criteria (15 listed)
- History of CABG;
- In stent restenosis;
- Patient with intolerance or contra-indications to treatment with aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, heparin, contrast media;
- Patient on chronic treatment with oral anticoagulants;
- Patient with neoplastic or rheumatic diseases;
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
Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification.
Time frame: hour 48
Number of patients with intracranial hemorrhage or a ≥5 g/dl decrease in hemoglobin concentration or a ≥15 % absolute decrease in hematocrit.
5 secondary outcomes
Efficacy endpoint: Long-term major adverse cardiac and cerebrovascular events MACCE (eg Death from any cause, Any Myocardial infarction, Revascularization, Stroke)
Time frame: hour 48 and day 30
Assessment of platelet reactivity
Time frame: Day 0
Number of Participants with stent thrombosis
Time frame: hour 48
Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.
Time frame: Day 30
Time to Coronary Artery Bypass Graft (CABG)
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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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.
Alfredo Marchese, MD, PhD principal investigator
Ospedale Santa Maria (BA)
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 Coronary Disease, run by Fondazione GISE Onlus at 1 site in Italy.
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 7 inclusion and 15 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 28 Jul 2022. 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 Italy. 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?
Contact Alfredo Marchese, MD, PhD (+390805040376, alfma@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification. (time frame: hour 48). 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 28 Jul 2022.