Coronary Artery DiseaseSDD-PROCAPENCT07830784
Same-Day Discharge After Elective Transradial Percutaneous Coronary Intervention: A Pilot Randomized Trial
A study testing same day discharge and Conventional Hospitalization in people with Coronary Artery Disease and Chronic Coronary Syndrome, run by PAULO CASTRO CHERPAK at 1 site in Brazil.
Trial summary
This single-center pilot randomized trial evaluated the safety and feasibility of same-day discharge (within 6 hours) compared with conventional overnight hospitalization (≥24 hours) in patients with chronic coronary artery disease undergoing successful elective transradial PCI in a Brazilian public tertiary center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Chronic Coronary Syndrome, Elective Percutaneous Coronary Intervention
- What is being tested?
- same day discharge and Conventional Hospitalization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jul 2025to 29 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 with chronic CAD undergoing successful elective transradial PCI; written informed consent.
Who cannot join
- LVEF ≤40%; MI within 14 days; creatinine clearance ≤45 mL/min; hemoglobin ≤10 g/dL; platelets ≤100,000/µL; INR >1.5; allergy to aspirin, clopidogrel, or iodinated contrast; procedural (angiographic or clinical) complications; access-site complications requiring prolonged monitoring.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Same-Day Discharge After Elective Transradial Percutaneous Coronary Intervention: A Pilot Randomized Clinical Trial
This single-center pilot randomized trial evaluated the safety and feasibility of same-day discharge (within 6 hours) compared with conventional overnight hospitalization (≥24 hours) in patients with chronic coronary artery disease undergoing successful elective transradial PCI in a Brazilian public tertiary center. Participants were followed by structured telemedicine consultation at 7 days.
Read the detailed description
Adults (≥18 years) with chronic CAD scheduled for elective transradial PCI were screened. After successful PCI and confirmation of eligibility, participants were randomized 1:1 (computer-generated sequence; allocation concealment via sequentially numbered opaque sealed envelopes) to same-day discharge (≤6 h, minimum 3 h monitoring with clinical assessment, ECG and radial access evaluation) or conventional hospitalization (≥24 h). Follow-up was performed by an outcome assessor blinded to allocation via structured 7-day telemedicine consultation. Pilot/feasibility design; the full confirmatory trial targets 232 participants (116/group).
- Conditions
- Coronary Artery Disease, Chronic Coronary Syndrome, Elective Percutaneous Coronary Intervention
- Being tested
- same day discharge, Conventional Hospitalization
- Keywords
- same-day discharge, transradial access, elective PCI, telemedicine, public healthcare system
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
same day dischargeBehavioural
discharge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up.
Conventional HospitalizationBehavioural
overnight stay ≥24 h per institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Same-Day Discharge | Experimental | discharge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up. Receives: Behavioral: same day discharge |
| Conventional Hospitalization | Active comparator | overnight stay ≥24 h per institutional protocol. Receives: Behavioral: Conventional Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse clinical events
All-cause death, myocardial infarction, unplanned revascularization, stroke, hospital readmission, or major bleeding (BARC ≥3)
Measured: 7 days after PCI
Secondary outcomes (3)
Emergency department visits
Any unplanned visit to an emergency department or urgent-care unit during follow-up, ascertained by the blinded assessor using the standardized structured telemedicine clinical follow-up form.
Measured: 7 days after PCI
Recurrent chest pain
Self-reported recurrent chest pain, assessed by the blinded assessor during the standardized structured telemedicine (video) consultation using a predefined symptom checklist within the clinical follow-up form (presence vs. absence).
Measured: 7 days after PCI
Radial access-site complications
Radial access-site complications (ARC-aligned; hematoma grades)
Measured: 7 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start4 Jul 2025
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAULO CASTRO CHERPAK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PAULO CASTRO CHERPAK, University of Pernambuco
- Investigators
- Audes D Feitosa, PhD, Study director, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830784
- Sponsor's protocol ID
- SDD-PROCAPE-2025
- Other IDs
- 88019325.1.0000.5192, 7.667.758
- Acronym
- SDD-PROCAPE
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data available upon reasonable request, subject to approval by the institutional research ethics committee (CEP HUOC/PROCAPE, cep\_huoc.procape@upe.br); requests to the ethics committee, not to a single author.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Same-Day Discharge After Elective Transradial Percutaneous Coronary Intervention: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07830784
- Acronym / sponsor ID
- SDD-PROCAPE / SDD-PROCAPE-2025
- Conditions
- Coronary Artery Disease, Chronic Coronary Syndrome, Elective Percutaneous Coronary Intervention
- Keywords
- same-day discharge, transradial access, elective PCI, telemedicine, public healthcare system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- PAULO CASTRO CHERPAKUniversity, hospital or other
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 21 Sep 2026 (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.
This single-center pilot randomized trial evaluated the safety and feasibility of same-day discharge (within 6 hours) compared with conventional overnight hospitalization (≥24 hours) in patients with chronic coronary artery disease undergoing successful elective transradial PCI in a Brazilian public tertiary center. Participants were followed by structured telemedicine consultation at 7 days.
Detailed description
Adults (≥18 years) with chronic CAD scheduled for elective transradial PCI were screened. After successful PCI and confirmation of eligibility, participants were randomized 1:1 (computer-generated sequence; allocation concealment via sequentially numbered opaque sealed envelopes) to same-day discharge (≤6 h, minimum 3 h monitoring with clinical assessment, ECG and radial access evaluation) or conventional hospitalization (≥24 h). Follow-up was performed by an outcome assessor blinded to allocation via structured 7-day telemedicine consultation. Pilot/feasibility design; the full confirmatory trial targets 232 participants (116/group).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same-Day Discharge | Experimental | Behavioral: same day dischargedischarge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up. |
| Conventional Hospitalization | Active comparator | Behavioral: Conventional Hospitalizationovernight stay ≥24 h per institutional protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults ≥18 with chronic CAD undergoing successful elective transradial PCI; written informed consent.
Key exclusion criteria (1 listed)
- LVEF ≤40%; MI within 14 days; creatinine clearance ≤45 mL/min; hemoglobin ≤10 g/dL; platelets ≤100,000/µL; INR >1.5; allergy to aspirin, clopidogrel, or iodinated contrast; procedural (angiographic or clinical) complications; access-site complications requiring prolonged monitoring.
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 |
|---|---|---|
| same day dischargedischarge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up. | Behavioural | Same-Day Discharge |
| Conventional Hospitalizationovernight stay ≥24 h per institutional protocol. | Behavioural | Conventional Hospitalization |
Primary outcome
Composite of major adverse clinical events
Time frame: 7 days after PCI
All-cause death, myocardial infarction, unplanned revascularization, stroke, hospital readmission, or major bleeding (BARC ≥3)
3 secondary outcomes
Emergency department visits
Time frame: 7 days after PCI
Recurrent chest pain
Time frame: 7 days after PCI
Radial access-site complications
Time frame: 7 days after PCI
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data available upon reasonable request, subject to approval by the institutional research ethics committee (CEP HUOC/PROCAPE, cep_huoc.procape@upe.br); requests to the ethics committee, not to a single author.
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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.
Audes D Feitosa, PhD study director
University of Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing same day discharge and Conventional Hospitalization in people with Coronary Artery Disease and Chronic Coronary Syndrome, run by PAULO CASTRO CHERPAK at 1 site in Brazil.
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 1 inclusion and 1 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 21 Sep 2026. 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 Brazil. 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?
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?
Composite of major adverse clinical events (time frame: 7 days after PCI). 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 21 Sep 2026.