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Completed

NCT Number: NCT07830784

Same-Day Discharge After Elective Transradial Percutaneous Coronary Intervention: A Pilot Randomized 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chronic Coronary Syndrome Coronary Disease Elective Percutaneous Coronary Intervention Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PROCAPE

Recife, Pernambuco, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 with chronic CAD undergoing successful elective transradial PCI; written informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

same day discharge

Behavioral

discharge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up.

Conventional Hospitalization

Behavioral

overnight stay ≥24 h per institutional protocol.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Emergency department visits

    Time frame: 7 days after PCI

    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.

  2. Recurrent chest pain

    Time frame: 7 days after PCI

    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).

  3. Radial access-site complications

    Time frame: 7 days after PCI

    Radial access-site complications (ARC-aligned; hematoma grades)

Sponsors and collaborators

Lead sponsor

PAULO CASTRO CHERPAK

Other

Registry information

Official study title

Safety and Feasibility of Same-Day Discharge After Elective Transradial Percutaneous Coronary Intervention: A Pilot Randomized Clinical Trial

Acronym: SDD-PROCAPE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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